Caravel CRV135-19PRecalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 04547327108775), received between May 14, 2017 and Jun 9, 2026 — classified as 27 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (22 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2026Material Fragmentation

  THE TIP OF THE MICROCATHETER CAME OFF DURING PROCEDURE. THEY TRIED TO RETRIEVE IT AND WERE UNSUCCESSFUL. THE CARAVEL WAS USED IN THE DISTAL LAD AND THE TIP CAME OFF IN THE PATIENTS BODY AND WAS NOT ABLE TO BE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25443504 ↗
• MalfunctionMar 2, 2026Break; Material Fragmentation

  WHILE CROSSING THE CIRC TO THE OM [OBTUSE MARGINAL] LESION. WHEN DR PULLED THE CARAVEL MICRO CATHETER BACK, HE SAW THAT THE TIP WAS NOT MOVING ON XRAY FLUORO AND HAD BROKEN OFF THE CARAVEL MICROCATHETER. HE RECAPTURED THE BROKEN TIP IN THE GUIDE CATHETER AND REMOVED EVERYTHING ON THE WIRE. WHILE LOOKING AT THE BROKEN TIP WHICH WAS AROUND 1MM IN SIZE THE DR DROPPED IT ON THE SCRUB TABLE AND IT ROLLED OFF. [REDACTED] WITNESSED DR DROP THE PIECE, BUT THEY COULD NOT LOCATE IT AFTERWARDS. DR THEN REWIRED LESION AND USED DIFFERENT BRAND OF MICROCATHETER TO PROCEED WITH CASE.

  Patient problems: Insufficient Information

  MAUDE report 24489766 ↗
• InjuryFeb 16, 2026Material Separation

  IT WAS REPORTED THAT AN ASAHI CARAVEL MICROCATHETER WAS USED FOR A PERCUTANEOUS CORONARY INTERVENTION (PCI) TO TREAT A CHRONIC TOTAL OCCLUSION (CTO) IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE TIP OF THE CARAVEL MICROCATHETER WAS TORN OFF. AN ATTEMPT WAS MADE TO RETRIEVE THE CATHETER TIP FRAGMENT USING A SNARE. AS A RESULT, THE CATHETER TIP FRAGMENT COULD NOT BE RETRIEVED. THE PHYSICIAN DECIDED TO LEAVE THE TIP FRAGMENT IN SITU. BLOOD FLOW COULD NOT BE REESTABLISHED. IT WAS INFORMED THAT THERE WAS NO ADVERSE PATIENT EFFECT.

  Patient problems: Foreign Body In Patient

  MAUDE report 24341906 ↗
• MalfunctionFeb 6, 2026Material Fragmentation

  DR. (B)(6) HAD THE TIP OF A CARAVEL COME OFF IN A PATIENT. DR. (B)(6) REMOVED THE TIP WITH A SNARE.

  Patient problems: Insufficient Information

  MAUDE report 24279071 ↗
• MalfunctionFeb 13, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED TO TREAT A HEAVILY CALCIFIED 99% STENOSIS IN THE RIGHT CORONARY ARTERY (RCA) FOR A PATIENT WITH NON-ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION (NSTEMI). AN ASAHI CARAVEL MICROCATHETER WAS ADVANCED OVER A NON-ASAHI GUIDE WIRE AND WAS DELIVERED TO THE HEAVILY TORTUOUS, CALCIFIED LESION. THE GUIDE WIRE WAS EXCHANGED FOR A NON-ASAHI ROTA WIRE AND THEN A RUN THROUGH GUIDE WIRE. WHEN A NON-ASAHI TRAPPER EXCHANGE DEVICE WAS USED TO REMOVE THE CARAVEL MICROCATHETER, THE CARAVEL MICROCATHETER WAS FELT LIKE STUCK, AND THE CATHETER TIP WAS FOUND TORN OFF AND REMAINED ON THE GUIDE WIRE. THE SEPARATED CATHETER TIP WAS REMOVED TOGETHER WITH THE GUIDE WIRE. THE PROCEDURE WAS COMPLETED WITHOUT ANY ISSUE. IT WAS INFORMED THAT PATIENT'S HEALTH CONDITION WAS NORMAL AFTER THE PROCEDURE, BUT THE PATIENT PASSED AWAY DUE TO COMORBID ISSUE UNRELATED TO THIS INCIDENT AFTER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21372282 ↗
• MalfunctionJan 31, 2025Crack; Material Fragmentation; Crack; Material Fragmentation

  CARAVEL WAS ADVANCED IN A NORMAL FASHION OVER A RUNTHROUGH GUIDEWIRE IN AN N-STEMI CASE ON A 74-YEAR-OLD FEMALE'S RCA. THE VESSEL HAD A 99% CALCIFIED, TORTUOUS LESION. CARAVEL WAS USED TO EXCHANGE TO ROTO WIRE, AND AFTER ROTO, IT WAS EXCHANGED BACK TO RUNTHROUGH WIRE. WHILE REMOVING CARAVEL WITH TRAPPER, CARAVEL SEEMED TO BE STUCK. AS THEY WENT TO A BALLOON LESION, THEY NOTICED THAT 1MM OF THE DISTAL TIP HAD CRACKED ON THE WIRE IN THE RCA. MD REMOVED THE WIRE WITH THE ENTIRE GUIDEWIRE SYSTEM. THE 1MM OF CARAVEL CAME OUT. THERE WAS NO PATIENT INJURY. MD COMPLETED THE CASE IN THE NORMAL FASHION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21289020 ↗
• MalfunctionDec 10, 2024Material Fragmentation; Material Fragmentation

  THE TIP OF A CARAVEL MICROCATHETER FRAGMENTED INTO THE CIRCUMFLEX CORONARY ARTERY VESSEL. ALL FRAGMENTS WERE RETRIEVED SUCCESSFULLY. THE CARDIAC CATHETERIZATION WAS COMPLETED SUCCESSFULLY. THERE WAS NO HARM TO THE PATIENT OR SUBSEQUENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20898234 ↗
• InjuryDec 20, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  SUS VOLUNTARY EVENT REPORT NUMBER: MW5096830 WAS RECEIVED FROM THE US DISTRIBUTOR. IT WAS REPORTED AS FOLLOWS: RETAINED MICROCATHETER "9/" MD USING AN ASAHI CARAVEL MICROCATHETER DURING PCI OF A CHRONIC TOTAL OCCLUSION. AS HE PULLED BACK, THE TIP OF THE CATHETER DISLODGED MID RCA AND WAS UNABLE TO BE RETRIEVED. IT WAS FELT THAT THE RIGHT LESION WAS THE CAUSE, NOT A FAULTY PRODUCT. COMPLICATION WAS DISCUSSED WITH PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11043307 ↗
• MalfunctionDec 16, 2020Detachment of Device or Device Component

  DR. DELEON DESCRIBES THIS IS A NO WIN SITUATION. HE HAD MADE SEVERAL ATTEMPTS USING MULTIPLE MICRO CATHETERS CROSSING A CALCIFIED LESION WITH NO SUCCESS WITH ANY MC OTHER THAN THE CARAVEL. UPON REPLACING THE WIRE WITH A ROTAWIRE, THE TIP OF THE CARAVEL CAME..."PULLED" OFF. THE PROCEDURE WAS STILL PERFORMED WITH NO HARM TO THE PATIENT. THE TIP CAME OFF WITH THE WIRE AND IS IN THE PACKAGING ACCORDING TO THE SCRUB TECHNICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11015751 ↗
• InjurySep 10, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PCI WAS PERFORMED TO TREAT A SEVERELY TORTUOUS, MODERATELY CALCIFIED, 90-99% OCCLUSION IN THE BIFURCATION OF THE LCX AND OM. THE TIP OF AN ASAHI CARAVEL MICROCATHETER BROKE OFF IN THE PATIENT'S LCX WHEN TRYING TO WITHDRAW THE CARAVEL OVER AN ASAHI GRAND SLAM GUIDE WIRE. THE SEPARATED TIP REMAINED ON THE GUIDE WIRE SO THAT THE GUIDE WIRE WAS PULLED BACK INTO A GUIDE EXTENSION CATHETER TO SUCCESSFULLY RETRIEVE THE SEPARATED TIP. THE PATIENT WAS IN STABLE AFTER THE PROCEDURE WITHOUT ANY ADVERSE EFFECTS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10512704 ↗
• MalfunctionAug 25, 2020Break

  CARAVEL'S TIP BROKE OFF IN THE PATIENT'S CX WHEN TRYING TO WITHDRAW THE CARAVEL OVER THE GRAND SLAM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10451682 ↗
• InjuryAug 16, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TARGET RCA WAS A MODERATE SIZED DOMINANT VESSEL WITH MULTIPLE LESIONS: 50% STENOSED OSTIAL LESION; PROXIMAL 90% AND 80% SEQUENTIAL STENOSES WITH SEVERE CALCIFICATION; MID SEGMENT 95% STENOSIS WITH SEVERE CALCIFICATION; AND DISTAL SEGMENT 70% STENOSIS JUST AT THE BIFURCATION TO THE MODERATE SIZED PDA AND A SMALL RPL BRANCH. DURING AN RCA INTERVENTIONAL PROCEDURE, AN AL 0.75 GUIDE CATHETER WAS MANIPULATED IT TO SELECTIVELY ENGAGE THE RCA. A RUNTHROUGH GUIDE WIRE WAS USED TO CROSS THE PROXIMAL LESION. A FINECROSS MICROCATHETER WAS UNABLE TO CROSS AND "TRAPPED" OUT TO EXCHANGE FOR AN ASAHI CARAVEL MICROCATHETER. THE CARAVEL PASSED THE PROXIMAL LESION, BUT COULD NOT ADVANCE BEYOND THE MID LESION. A ROTAWIRE WAS SWAPPED FOR THE RUNTHROUGH. THE CARAVEL WAS THEN BACKED OUT AND BECAME "ENTRAPPED" AT THE TIP OF THE GUIDE CATHETER. A PARALLEL WIRE (WHISPER) WAS USED AND DILATION WAS PERFORMED WITH A 3.0 COMPLIANT BALLOON TO ASSIST WITH CARAVEL REMOVAL. IT WAS ABLE TO PULL THE WHOLE UNIT WITHOUT DIFFICULTY. THE GUIDE WIRE WAS ALSO REMOVED AND THE GUIDE CATHETER WAS CHANGED FOR IMPROVED SUPPORT. THE RCA WAS RE-WIRED WITH A WHISPER GUIDE WIRE. A TURNPIKE AND AN ASAHI COR

  Patient problems: Device Embedded In Tissue or Plaque; Vessel Or Plaque, Device Embedded In

  MAUDE report 10411907 ↗
• InjuryAug 14, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TARGET RCA WAS A MODERATE SIZED DOMINANT VESSEL WITH MULTIPLE LESIONS: 50% STENOSED OSTIAL LESION; PROXIMAL 90% AND 80% SEQUENTIAL STENOSES WITH SEVERE CALCIFICATION; MID SEGMENT 95% STENOSIS WITH SEVERE CALCIFICATION; AND DISTAL SEGMENT 70% STENOSIS JUST AT THE BIFURCATION TO THE MODERATE SIZED PDA AND A SMALL RPL BRANCH. DURING AN RCA INTERVENTIONAL PROCEDURE, AN AL 0.75 GUIDE CATHETER WAS MANIPULATED IT TO SELECTIVELY ENGAGE THE RCA. A RUN THROUGH GUIDE WIRE WAS USED TO CROSS THE PROXIMAL LESION. A FINE CROSS MICROCATHETER WAS UNABLE TO CROSS AND "TRAPPED" OUT TO EXCHANGE FOR AN ASAHI CARAVEL MICROCATHETER. THE CARAVEL PASSED THE PROXIMAL LESION, BUT COULD NOT ADVANCE BEYOND THE MID LESION. A ROTOWIRE WAS SWAPPED FOR THE RUN THROUGH. THE CARAVEL WAS THEN BACKED OUT AND BECAME "ENTRAPPED" AT THE TIP OF THE GUIDE CATHETER. A PARALLEL WIRE (WHISPER) WAS USED AND DILATION WAS PERFORMED WITH A 3.0 COMPLIANT BALLOON TO ASSIST WITH CARAVEL REMOVAL. IT WAS ABLE TO PULL THE WHOLE UNIT WITHOUT DIFFICULTY. THE GUIDE WIRE WAS ALSO REMOVED AND THE GUIDE CATHETER WAS CHANGED FOR IMPROVED SUPPORT. THE RCA WAS RE-WIRED WITH A WHISPER GUIDE WIRE. A TURNPIKE AND AN ASAHI

  Patient problems: Device Embedded In Tissue or Plaque; Vessel Or Plaque, Device Embedded In

  MAUDE report 10406198 ↗
• MalfunctionAug 3, 2020Entrapment of Device; Failure to Advance

  DURING RCA INTERVENTIONAL PROCEDURE, RUNTHROUGH WIRE USED TO CROSS RCA LESION. FINECROSS UNABLE TO CROSS AND "TRAPPED" OUT TO EXCHANGE FOR CARAVEL. CARAVEL PASSED THE LESION, BUT COULD NOT ADVANCE BEYOND MID-LESION. ROTA WIRE SWAPPED FOR RUNTHROUGH. CARAVEL THEN BACKED OUT AND BECAME "ENTRAPPED" AT THE TIP OF THE GUIDE CATHETER. PARALLEL WIRE USED AND PTCA DEPLOYED TO ASSIST WITH CARAVEL REMOVAL. CATHETER AND WIRE THEN REMOVED AND GUIDE CHANGED FOR IMPROVED SUPPORT. RCA RE-WIRED WITH RUNTHROUGH. TURNPIKE AND CORSAIR PRO USED TO CROSS THE LESION WITH NO SUCCESS. A SECOND CARAVEL WAS THEN OPENED AND USED TO ADVANCE INTO THE RCA WHICH PASSED THE PROXIMAL AND MID LESIONS. TRUE LUMEN CONFIRMATION OF WIRE WAS MADE AND RUNTHROUGH EXCHANGED FOR ROTAWIRE IN ANTICIPATION OF ROTATIONAL ATHERECTOMY. CARAVEL WAS THEN BACKED OUT ONLY TO BE ENTRAPPED AT THE TIP OF THE GUIDE LIKE THE PREVIOUS CARAVEL MICRO CATHETER. ROTATIONAL ATHERECTOMY WAS PERFORMED (EVEN WITH CARAVEL TIP ON IT DISTALLY) ON THE PROXIMAL SECTION OF THE VESSEL WITH NO SUCCESS IN THE MID. PTCA PERFORMED ON MID LESION WITH IMPROVED FLOW. PROCEDURE HALTED DUE TO TIME OF FLUOROSCOPY AND CONTRAST LIMITATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10359946 ↗
• MalfunctionAug 3, 2020Entrapment of Device; Failure to Advance

  DURING RCA INTERVENTIONAL PROCEDURE, RUNTHROUGH WIRE USED TO CROSS RCA LESION. FINECROSS UNABLE TO CROSS AND "TRAPPED" OUT TO EXCHANGE FOR CARAVEL. CARAVEL PASSED THE LESION, BUT COULD NOT ADVANCE BEYOND MID-LESION. ROTA WIRE SWAPPED FOR RUNTHROUGH. CARAVEL THEN BACKED OUT AND BECAME "ENTRAPPED" AT THE TIP OF THE GUIDE CATHETER. PARALLEL WIRE USED AND PTCA DEPLOYED TO ASSIST WITH CARAVEL REMOVAL. CATHETER AND WIRE THEN REMOVED AND GUIDE CHANGED FOR IMPROVED SUPPORT. RCA RE-WIRED WITH RUNTHROUGH. TURNPIKE AND CORSAIR PRO USED TO CROSS THE LESION WITH NO SUCCESS. A SECOND CARAVEL WAS THEN OPENED AND USED TO ADVANCE INTO THE RCA WHICH PASSED THE PROXIMAL AND MID LESIONS. TRUE LUMEN CONFIRMATION OF WIRE WAS MADE AND RUNTHROUGH EXCHANGED FOR ROTAWIRE IN ANTICIPATION OF ROTATIONAL ATHERECTOMY. CARAVEL WAS THEN BACKED OUT ONLY TO BE ENTRAPPED AT THE TIP OF THE GUIDE LIKE THE PREVIOUS CARAVEL MICRO CATHETER. ROTATIONAL ATHERECTOMY WAS PERFORMED (EVEN WITH CARAVEL TIP ON IT DISTALLY) ON THE PROXIMAL SECTION OF THE VESSEL WITH NO SUCCESS IN THE MID. PTCA PERFORMED ON MID LESION WITH IMPROVED FLOW. PROCEDURE HALTED DUE TO TIME OF FLUOROSCOPY AND CONTRAST LIMITATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10359755 ↗
• InjuryMay 20, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF AN ASAHI CARAVEL MICROCATHETER BROKE OFF DURING A PCI TO TREAT AN IN-STENT CTO. THE MICROCATHETER WAS POSITIONED ANTEGRADELY WHEN ITS TIP CAME FREE. THE PHYSICIAN COMMENTED THAT IT MIGHT HAVE BEEN SNAGGED BEHIND A STENT STRUT. THE SEPARATED TIP WAS SAFELY REMOVED WITH A BALLOON. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10073677 ↗
• MalfunctionMay 8, 2020Detachment of Device or Device Component

  DOCTOR HAD AN IN-STENT CTO AND FROM AN ANTEGRADE POSITION HAD A CARAVEL TIP COME FREE. STATES IT MAY HAVE BEEN SNAGGED BEHIND A STENT STRUT, BUT COULDN'T BE EXACTLY SURE HOW IT CAME FREE AND SAID DEVICE WAS NOT TORQUED. TIP WAS SAFELY REMOVED WITH A BALLOON

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10039201 ↗
• InjuryMar 11, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF AN ASAHI CARAVEL MICROCATHETER BECAME SEPARATED DURING A PCI TO TREAT A MILDLY CALCIFIED 75-90% OCCLUSION IN THE LCX. THE MICROCATHETER WAS ADVANCED WITH DIFFICULTIES THROUGH FIRM PLAQUE OF THE LESION. RESISTANCE WAS MET DURING REMOVAL AND THE TIP SHEARED OFF. THE SEPARATED TIP REMAINED IN THE LESION. ANOTHER CARAVEL MICROCATHETER WAS USED TO CONTINUE THE PROCEDURE. A SNARE WAS USED TO SUCCESSFULLY RETRIEVE THE SEPARATED TIP. NOTHING WAS LEFT BEHIND. THERE WERE NO ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9821722 ↗
• InjuryFeb 18, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF AN ASAHI CARAVEL MICROCATHETER WAS SEPARATED AND REMAINED IN THE PATIENT DURING A PCI TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED 75-90% OCCLUSION IN THE RCA. THE LESION WAS WIRED SUCCESSFULLY WITH AN ASAHI FIELDER FC GUIDE WIRE AND THE MICROCATHETER WAS PLACED OVER THE GUIDE WIRE AND SUCCESSFULLY NAVIGATED ALL THE WAY DISTAL ACROSS THE LESION. THE GUIDE WIRE WAS PULLED AND REPLACED WITH A ROTA WIRE FLOPPY GUIDE WIRE. THE MICROCATHETER WAS BEING REMOVED BUT GOT STUCK IN THE PROXIMAL HIGHLY CALCIFIED 1/3RD OF THE RCA. AT THE POINT WHERE THE CATHETER LOOKED TO BE STUCK, THE PHYSICIAN CONTINUED TO PULL AND NOTICED THE TIP OF THE MICROCATHETER SEPARATED FROM THE SHAFT. SEVERAL ATTEMPTS WERE MADE TO RECOVER THE TIP BUT THEY WERE NOT SUCCESSFUL. ANGIOPLASTY AND STENT PROCEDURE ON THIS PATIENT'S ARTERY WERE UNABLE TO BE PERFORMED DUE TO ANATOMY.

  Patient problems: Device Embedded In Tissue or Plaque; Vessel Or Plaque, Device Embedded In

  MAUDE report 9724048 ↗
• InjuryFeb 4, 2020Difficult to Remove; Material Separation

  RCA WAS WIRED SUCCESSFULLY WITH A FIELDER FC WIRE AND CARAVEL CATHETER WAS PLACED OVER THE FIELDER AND SUCCESSFULLY NAVIGATED ALL THE WAY DISTAL ACROSS THE LESION. THE FIELDER FC WIRE WAS PULLED AND REPLACED WITH A ROTOBLATOR FLOOPY WIRE. THE CARAVEL CATHETER WAS BEING REMOVED BUT GOT STUCK IN THE PROXIMAL HIGHLY CALCIFIED 1/3RD OF THE RCA. AT THE POINT WHERE THE CATHETER LOOKED TO BE STUCK, THE PHYSICIAN CONTINUED TO PULL AND NOTICED THE TIP OF THE CARAVEL SEPARATED FROM THE SHAFT. SEVERAL ATTEMPTS WERE MADE TO RECOVER THE TIP BUT THEY WERE NOT SUCCESSFUL.

  Patient problems: Foreign Body In Patient

  MAUDE report 9668979 ↗
• InjuryJan 9, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF AN ASAHI CARAVEL MICROCATHETER BECAME SEPARATED DURING A PERCUTANEOUS PERIPHERAL INTERVENTION TO TREAT A SEVERELY TORTUOUS, SEVERELY CALCIFIED 90-99% OCCLUSION IN THE POSTERIOR TIBIAL VESSEL. WHEN THE CARAVEL WAS INSERTED AND ADVANCED TO THE CALCIUM, THE TIP BECAME WEDGED INTO THE CALCIUM AND AS THE OPERATOR ATTEMPTED TO ADVANCE OR RETRACT THE CATHETER, SLIGHT TORQUE WAS APPLIED AND THE TIP OF THE CARAVEL CAME OFF ON THE CONCOMITANT NON-ASAHI GUIDE WIRE. AFTER THE OPERATOR NOTICED THAT THE TIP OF THE CARAVEL WAS SEPARATED FROM THE CATHETER, HE SIMPLY ADVANCED A SECOND BALLOON DOWN TO THE TIP, INFLATED THE BALLOON AND DRAGGED THE TIP (ON THE GUIDE WIRE) BACK TO THE SHEATH AND WAS SAFELY EXTRACTED FROM THE PATIENT. PATIENT OUTCOME WAS EXCELLENT. GRANTED THE CASE WENT LONGER DUE TO RETRIEVAL OF THE SEPARATED TIP, THE PROCEDURE WAS AN OVERALL SUCCESS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9567493 ↗
• InjuryDec 23, 2019Failure to Advance; Detachment of Device or Device Component

  HIGHLY CACIFIC POSTERIOR TIBIAL VESSEL WHERE CARAVEL WAS INSERTED AND ADVANCED TO THE CALCIUM. THE TIP BECAME WEDGED INTO THE CALCIUM AND AS THE OPERATOR ATTEMPTED TO ADVANCE OR RETRACT THE CATHETER, SLIGHT TORQUE WAS APPLIED AND THE TIP OF THE CARAVEL CAME OFF ON THE ABBOTT COMMAND WIRE. AFTER THE OPERATOR NOTICED THAT THE TIP OF THE CARAVEL WAS SEPARATED FROM THE CATHETER, HE SIMPLY ADVANCED A SECOND BALLOON DOWN TO THE TIP, INFLATED THE BALLOON AND DRAGGED THE TIP (ON THE COMMAND WIRE) BACK TO THE SHEATH AND WAS SAFELY EXTRACTED FROM THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9513334 ↗
• InjuryNov 11, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED TO TREAT A SEVERELY CALCIFIED SUBTOTAL OCCLUSION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. ABLATION WITH ROTABLATOR WAS PLANNED TO BE PERFORMED. AN ASAHI MICROCATHETER WAS ADVANCED INTO THE LESION. DURING REMOVAL FROM THE ARTERY, THE CATHETER TIP BECAME SEPARATED IN THE LESION. THE PROCEDURE WAS UNSUCCESSFUL AND THE PATIENT WENT FOR BYPASS SURGERY. THE SEPARATED TIP WAS LEFT IN THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque; Vessel Or Plaque, Device Embedded In

  MAUDE report 9307203 ↗
• MalfunctionNov 5, 2019Break

  CALCIFIED SUB TOTAL PROXIMAL LAD. PLAN WAS TO ROTA THE LESION. WAS UNSUCCESSFUL DUE TO TIP OF MICROCATHETER BREAKING OFF IN THE ARTERY. PATIENT WENT FOR BY PASS SURGERY. TIP LEFT IN PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9279615 ↗
• MalfunctionJul 22, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF AN ASAHI MICROCATHETER SEPARATED DURING A PCI TO TREAT A MILDLY TORTUOUS, MODERATELY CALCIFIED 90-99% STENOSIS IN THE MID LAD. WHILE TRYING TO PUSH THE CATHETER THROUGH THE LESION, IT BECAME STUCK. UPON WITHDRAWING FROM THE LESION, ABOUT 2MM OF THE TIP WAS SEPARATED FROM THE REST OF THE CATHETER BUT REMAINED ON THE WIRE. THE PHYSICIAN WAS ABLE TO REMOVE THE CATHETER AND THE WIRE AT THE SAME TIME. WHILE WIRE POSITION WAS LOST THE ENTIRE WIRE/DEVICE WAS REMOVED AND NO PARTICLE LEFT IN THE PATIENT. THERE WERE NO ADVERSE PATIENT EFFECTS. THE PHYSICIAN STATED HE DID NOT THINK THE PRODUCT WAS DEFECTIVE BUT RATHER A VERY DIFFICULT LESION TO TREAT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8814445 ↗