CXI G50001Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00827002500013), received between Jun 7, 2016 and Nov 11, 2024 — classified as 3 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Material Separation” (10 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 11, 2024Break; Break

  ADDITIONAL INFORMATION RECEIVED 20NOV2024. THE SEPARATED CXI WAS REMOVED TOGETHER WITH AN UNSPECIFIED SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20653745 ↗
• MalfunctionNov 17, 2023Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED 20NOV2023 STATING AN IPSILATERAL APPROACH WAS USED, THE TIP OF THE CXI SUPPORT CATHETER SEPARATED AND BROKE OFF INSIDE OF THE SHEATH. THE DEVICE WAS REMOVED FROM THE PATIENT WHILE INSIDE THE SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18161076 ↗
• MalfunctionAug 25, 2023Break; Break

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17624313 ↗
• MalfunctionDec 16, 2022Material Perforation; Material Perforation

  AS REPORTED, DURING A LEFT TIBIAL ANGIOPLASTY, ANOTHER MANUFACTURER'S WIRE GUIDE PERFORATED A CXI SUPPORT CATHETER 2-3 CM FROM THE DISTAL TIP. ACCESS WAS GAINED IN THE FEMORAL ARTERY. THE PATIENT'S ANATOMY WAS CALCIFIED. THE CATHETER AND WIRE WERE REMOVED FROM THE PATIENT AFTER THE PERFORATION WAS NOTED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15999427 ↗
• MalfunctionOct 4, 2022Break; Break

  AS REPORTED, UPON OPENING A CXI SUPPORT CATHETER'S PACKAGE FOR AN UNKNOWN PROCEDURE, THE HUB OF THE CATHETER WAS DETACHED. THE DEVICE WAS REPORTEDLY STORED AS REQUIRED AND NO DAMAGE WAS NOTED TO THE PACKAGING. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE, AND THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. UPON RETURN AND INITIAL EVALUATION OF THE DEVICE, THE CATHETER MATERIAL WAS SEPARATED WITHIN THE HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15539705 ↗
• MalfunctionJun 21, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING AN ANGIOGRAM INVOLVING A (B)(6) YEAR-OLD PATIENT OF UNKNOWN GENDER WITH A HISTORY OF VASCULAR DISEASE, THE HUB OF A CXI SUPPORT CATHETER SEPARATED FROM THE DEVICE. ACCESS WAS OBTAINED IN THE GROIN. THE CATHETER WAS INSIDE A 5 FRENCH ANSEL SHEATH OVER AN UNKNOWN MANUFACTURER'S 0.014 WIRE GUIDE. THE DEVICE WAS UP AND OVER THE BIFURCATION. UPON REMOVAL OF THE COMPLAINT DEVICE FROM THE PATIENT IN THE MIDDLE OF THE PROCEDURE, THE HUB DETACHED AND THE CATHETER WAS REMOVED WITH CLAMPS. ANOTHER MANUFACTURER'S CATHETER WAS USED TO COMPLETE THE PROCEDURE AND THE PATIENT'S OUTCOME WAS REPORTEDLY "GOOD". A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 8723889 ↗
• MalfunctionJun 10, 2019Material Separation; Material Separation

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8684219 ↗
• MalfunctionJan 10, 2019Material Separation; Material Separation

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8237220 ↗
• InjuryJul 18, 2018Difficult to Advance; Difficult to Advance

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Code Available

  MAUDE report 7698717 ↗
• MalfunctionMay 31, 2018Physical Property Issue; Physical Property Issue

  IT WAS REPORTED, THAT DURING AN UNSPECIFIED PROCEDURE, THE CXI SUPPORT CATHETER BECAME STUCK AT THE HUB OF THE CATHETER AND COULD NOT BE ADVANCED FURTHER. ANOTHER MANUFACTURER'S WIRE GUIDE WAS ADVANCED INTO THE COMPLAINT DEVICE FROM THE PROXIMAL END WHEN IT BECAME LODGED IN THE HUB. ANOTHER MANUFACTURER'S CATHETER WAS USED INSTEAD AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY PATIENT ADVERSE EFFECTS. UPON RECEIPT OF THE COMPLAINT DEVICE BY THE MANUFACTURER, IT WAS NOTED THE CATHETER HAD SKIVE DAMAGE (THIN LAYERS CUT OFF) WHICH RAN ALMOST THE FULL LENGTH OF THE DEVICE LEAVING THE BRAIDED WIRE OF THE SHAFT EXPOSED APPROXIMATELY 28.1CM FROM THE DISTAL TIP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7558532 ↗
• MalfunctionMay 29, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT DURING DILATION OF A CHRONIC TOTAL OBSTRUCTION (CTO) OF A MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA), THE CXI SUPPORT CATHETER WAS FOUND TO BE BROKEN AND SEPARATED UPON REMOVAL FROM THE PATIENT (REFER TO THIS REPORT) . A SECOND CXI SUPPORT CATHETER WAS USED AND IT, TOO, WAS FOUND TO BE BROKEN AND SEPARATED UPON REMOVAL FROM THE PATIENT (REFER TO MEDWATCH 1820334-2018-01536). DURING THE PROCEDURE ANOTHER MANUFACTURER'S 0.018 INCH WIRE GUIDE WAS ADVANCED CONTRALATERALLY FROM THE RIGHT FEMORAL ARTERY (FA) PAST THE CTO LESION (10CM IN LENGTH) IN THE LEFT SFA. THE CXI SUPPORT CATHETER WAS ADVANCED OVER THE WIRE GUIDE PAST THE TARGET LESION. UPON REMOVAL OF THE COMPLAINT DEVICE, THE PHYSICIAN REPORTEDLY FELT RESISTANCE AND APPLIED TORQUE PULLING ON IT FORCEFULLY. THE CXI SUPPORT CATHETER WAS SUCCESSFULLY REMOVED HOWEVER IT WAS OBSERVED TO BE BROKEN AND SEPARATED AT THAT TIME. NO SECTION OF THIS COMPLAINT DEVICE REMAINED IN THE PATIENT'S ANATOMY. A SECOND CXI SUPPORT CATHETER WAS ADVANCED OVER THE SAME WIRE GUIDE AND AGAIN, RESISTANCE WAS FELT UPON REMOVAL. THE PHYSICIAN APPLIED TORQUE AND PULLED FORCEFULLY IN ORDER TO SUCCESSFULLY REMOVE THIS SECOND COMPLA

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7550199 ↗
• MalfunctionDec 5, 2017Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN "IDE" PROCEDURE, THE CXI SUPPORT CATHETER SEPARATED WHILE IT WAS INSIDE OF THE PATIENT'S RENAL ARTERY. THE WIRE GUIDE WAS PULLED BACK, AND BOTH PIECES OF THE CATHETER CAME OUT OF THE PATIENT'S ANATOMY. THE CATHETER WAS NOTED TO HAVE BEEN EXTENSIVELY USED THROUGH TORTUOUS VESSELS, AND MULTIPLE STENTS THROUGHOUT THE PROCEDURE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7083448 ↗
• MalfunctionNov 20, 2017Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT DURING ENDOVASCULAR THERAPY (EVT) TO TREAT THE ANTERIOR AND POSTERIOR TIBIAL ARTERIES BELOW THE KNEE (BK) USING AN IPSILATERAL APPROACH FROM THE WRIST, THE PROXIMAL SIDE OF THE CXI SUPPORT CATHETER BECAME TWISTED. THE PHYSICIAN ATTEMPTED TO REMOVE THE CATHETER FROM THE PATIENT; HOWEVER, HE EXPERIENCED DIFFICULTY AND THE CATHETER SHAFT BECAME SEPARATED FROM THE HUB. DESPITE THE SEPARATION, THE DEVICE WAS ABLE TO BE REMOVED AND WAS REPLACED WITH ANOTHER CXI SUPPORT CATHETER. THE PROCEDURE WAS ABLE TO BE SUCCESSFULLY COMPLETED WITH THE REPLACEMENT DEVICE. THE PATIENT HAD MODERATE TO SEVERE CALCIFICATION, BUT NO SIGNIFICANT TORTUOSITY WAS OBSERVED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7046339 ↗
• InjuryNov 15, 2017Material Separation; Material Separation

  THIS WAS A LIMB SALVAGE CASE. PATIENT HAD RIGHT LEG TOTAL SFA AND ANTERIOR TIBIAL OCCLUSION, SEVERELY CALCIFIED, RECONSTITUTING AT DISTAL AT/DP. PHYSICIAN ATTEMPTED CROSSING THIS OCCLUSION RETROGRADE ACCESSING FROM DISTAL AT USING AN .018¿ 90CM CXI IT WAS REPORTED THAT DURING A LIMB SALVAGE PROCEDURE, THE CXI SUPPORT CATHETER BROKE. THE PATIENT HAD RIGHT LEG TOTAL SUPERFICIAL FEMORAL ARTERY (SFA) AND ANTERIOR TIBIAL OCCLUSION, SEVERELY CALCIFIED, RECONSTITUTING AT DISTAL AT/DP. THE PHYSICIAN WAS SUCCESSFUL IN CROSSING THIS OCCLUSION RETROGRADE ACCESSING FROM DISTAL AT USING AN .018¿ 90CM CXI SUPPORT CATHETER (MEDWATCH NUMBER: 1820334-2017-03743) AND A V18 WIRE. A PEDAL SHEATH WAS INITIALLY USED AND THEN REMOVED, AND THE CXI SUPPORT CATHETER WAS ADVANCED SHEATH-LESS. WHEN REMOVING THE CATHETER, IT SEPARATED ALONG THE SHAFT INTO TWO PORTIONS. BOTH PORTIONS WERE SUCCESSFULLY RETRIEVED BY PULLING ON THE CATHETER UNTIL FULLY REMOVED. THE PHYSICIAN ALSO ACCESSED THE RIGHT LEG FROM THE LEFT GROIN, THROUGH AN UP AND OVER APPROACH USING A 6FR TERUMO DESTINATION SHEATH. THE SAME WIRE THAT WAS ADVANCED FROM PEDAL ACCESS WAS PULLED FROM THE RIGHT GROIN THROUGH THE 6FR TERUMO DESTINATION SHEATH

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7033415 ↗
• MalfunctionNov 7, 2017Device Operates Differently Than Expected

  APPROACH WAS GAINED FROM THE COMMON FEMORAL ARTERY (CFA) CONTRALATERALLY. THE DEVICE WAS ADVANCED WITH THE AID OF ANOTHER MANUFACTURER'S WIRE GUIDE TO PASS THROUGH THE LESION, BUT TORQUE APPLIED TO THE WIRE GUIDE WOULD NOT TRANSMIT. THE PHYSICIAN REMOVED THE DEVICES AND APPLIED TORQUE TO THE WIRE GUIDE AT PROXIMAL SITE TO TEST THE TORQUE TRANSMISSION, BUT THE WIRE GUIDE TIP STILL WOULD NOT RESPOND. MOREOVER, WHEN THE CATHETER WAS FLUSHED AFTER THE ISSUE, METAL-LIKE SUBSTANCES CAME OUT FROM INNER LUMEN. ANOTHER CATHETER WAS USED TO FINISH THE PROCEDURE, AND THERE WERE NO PATIENT INJURIES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7006740 ↗
• MalfunctionNov 7, 2017Kinked; Sticking

  THE CXI WAS ADVANCED OVER AN UNKNOWN WIRE GUIDE DURING A TRAINING SESSION (NO PATIENT USE). THERE WAS AN ATTEMPT TO REMOVE THE WIRE GUIDE FROM THE CXI, BUT THE WIRE GUIDE BECAME STUCK. MORE FORCE WAS ADDED AND THE WIRE GUIDE COULD BE REMOVED FROM THE CXI ALTHOUGH THE CXI GOT KINKED. THE USER THEN NOTICED THAT AN UNKNOWN GREEN SUBSTANCE CAME OUT FROM THE INNER LUMEN OF THE CXI.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7006269 ↗
• MalfunctionNov 7, 2017Detachment Of Device Component

  APPROACHES WERE GAINED FROM BOTH THE LEFT FEMORAL ARTERY (FA) AND LEFT BRACHIAL ARTERY (BA) TO TREAT THE OCCLUDED EIA (EXTERNAL ILIAC ARTERY). THE LESION WAS SEVERE AND ALSO SEVERELY TORTUOUS. THE CXI WAS INSERTED FROM THE LEFT BA COMBINED WITH ANOTHER MANUFACTURER'S SHEATH OVER A DIFFERENT MANUFACTURER'S WIRE GUIDE. AN UNKNOWN SHEATH WAS INSERTED FROM THE LEFT FA. THE CXI WAS REMOVED FROM THE PATIENT ONCE AND FLUSHED. SUBSEQUENTLY, A GREEN UNKNOWN POWDER-LIKE SUBSTANCE CAME OUT FROM THE INNER LUMEN. THE PHYSICIAN NOTICED THAT THE COATING OF THE WIRE GUIDE WAS PULLED AWAY FROM THE POINT WHERE A TORQUER WAS ATTACHED, SO THE COATING MATERIAL MIGHT HAVE BEEN SCRAPED. THE DEVICE WAS CHANGED WITH ANOTHER SIZED CXI EVEN THOUGH THE PROCEDURE WAS REPORTEDLY FINISHED UNSUCCESSFULLY. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7006188 ↗
• MalfunctionNov 1, 2017Sticking

  THE DEVICE WAS ADVANCED FROM THE RIGHT FA (FEMORAL ARTERY) TO THE SEVERELY CALCIFIED LESION. WHEN THE USER WAS ADVANCING THE DEVICE THROUGH THE LESION, A WIRE GUIDE GOT STUCK INSIDE THE CXI. THIS WAS POSSIBLY DUE TO THE INNER LUMEN OF THE CXI BECOMING NARROWED DUE TO ADVANCEMENT WHILE APPLYING A TWIST TO THE DEVICE. IT WAS FURTHER NOTED THAT THE DEVICE WAS STRETCHED. ANOTHER CXI DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THIS PRODUCT PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6994365 ↗
• MalfunctionNov 1, 2017Kinked; Stretched

  THE PHYSICIAN CONFIRMED THAT THE CATHETER HAD A KINK NEAR THE HUB BEFORE FLUSHING THE DEVICE. ACCORDING TO THE PHYSICIAN, THERE WAS NO KINK WHEN THE DEVICE WAS REMOVED FROM THE PACKAGE. VISUAL EXAM OF THE DEVICE NOTED STRETCHING NEAR THE HUB. ANOTHER DEVICE OF DIFFERENT SIZE WAS USED INSTEAD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6992676 ↗
• MalfunctionOct 30, 2017Sticking

  THE DEVICE WAS ADVANCED THROUGH A 6FR SHEATH TO THE LESION OF THE POPLITEAL ARTERY BY CONTRALATERAL APPROACH. FIRST, THE WIRE GUIDE WAS ADVANCED THROUGH THE LESION, THEN, THE CXI ADVANCED OVER THE WIRE GUIDE, HOWEVER, THE CXI AND WIRE GUIDE GOT STUCK. THEREFORE, CXI AND WIRE GUIDE WERE REMOVED TOGETHER FROM THE PATIENT BODY, AND IT WAS REPLACED WITH THE SAME LOT # OF CXI. NO ADVERSE EFFECT TO THE PATIENT REPORTED. OF NOTE DEVICE IMAGING REVEALED STRETCHING OF THE CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6987071 ↗
• MalfunctionJun 23, 2017Kinked; Kinked

  IT WAS REPORTED THAT A CXI SUPPORT CATHETER WAS USED TO TREAT THE LESION IN BK REGION. THE CATHETER GOT KINKED DURING THE PROCEDURE AND BECAME IMPOSSIBLE TO USE. ANOTHER MANUFACTURER'S DEVICE WAS USED INSTEAD WITHOUT PROBLEMS. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6663968 ↗
• InjuryMay 11, 2017Material Separation; Material Separation

  IT WAS REPORTED DURING AN UNSPECIFIED PROCEDURE WHILE USING A CXI SUPPORT CATHETER, THE DEVICE WAS ADVANCED TO THE COMMON ILIAC ARTERY (CIA) WITH SEVERELY CALCIFIED CHRONIC TOTAL OCCLUSION (CTO) LESION BY CONTRALATERAL APPROACH. A WIRE GUIDE COULD PASS THROUGH THE LESION HOWEVER, THE CXI STOPPED ADVANCING, GOT STUCK AND SEPARATED. IT CANNOT BE DETERMINED WHICH WIRE GUIDE WAS USED WHEN THE SEPARATION OCCURRED. THE SEPARATED SEGMENT REMAINED IN THE CALCIFIED LESION, BUT THE DEVICE PORTION WAS RETRIEVED EVENTUALLY USING A SNARE DEVICE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; No Code Available

  MAUDE report 6560911 ↗
• MalfunctionFeb 28, 2017Material Separation; Material Separation

  IT WAS REPORTED, DURING AN ANGIOPLASTY PROCEDURE FOR A PATIENT WITH A HEAVILY CALCIFIED SUPERFICIAL FEMORAL ARTERY THE CXI SUPPORT CATHETER BROKE INTO PIECES. THE PHYSICIAN CROSSED THE LESION BY OBTAINING PETAL ACCESS AND SNARED THE WIRE THROUGH THE SHEATH. DUE TO THE HEAVY CALCIFICATION, THE CXI SUPPORT CATHETER GOT STUCK IN THE VESSEL ON THE WIRE [NON COOK]. UPON REMOVAL, THE CATHETER BROKE INTO 4 SEPARATE PIECES OUTSIDE THE BODY DUE TO TENSION. AS THE PHYSICIAN PULLED SOME OF THE CATHETER OUT, BREAKAGE WOULD OCCUR. ALL FRAGMENTS WERE REMOVED AND THE PROCEDURE WAS COMPLETED; THE PATIENT REMAINED UNHARMED.

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 6364089 ↗
• MalfunctionOct 20, 2016Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CONSUMER STATED THAT A FEMALE PATIENT PRESENTED WITH A DISTAL OCCLUSION AND UNDERWENT AN ANGIOPLASTY PROCEDURE (SURGICAL REPAIR OR UNBLOCKING OF A BLOOD VESSEL, ESPECIALLY A CORONARY ARTERY.) DURING THE PROCEDURE THERE WAS A FRAGMENTATION OF THE COLLECTOR TO A MINIMUM HANDLING DURING USE. DETACHMENT OF THE TERMINAL PORTION OF THE COLLECTOR (CONNECTED) VERY EASILY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6045892 ↗
• MalfunctionAug 23, 2016Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ANGIOGRAM OF THE LEG, THE PHYSICIAN TREATED A PROXIMAL AT LESION USING A 5FR SHEATH, V18 WIRE AND TWO CXI SUPPORT CATHETER'S .035 AND .018. THE PHYSICIAN BELIEVES HE WENT SUBINTIMAL WITH THE V18 WIRE AND .018 CATHETER. HE ATTEMPTED TO REMOVE THE V18 WIRE TO TAKE A PICTURE AND IT WAS STUCK IN THE .018 CATHETER. THE PHYSICIAN PULLED WITH A LOT OF FORCE AND THE HUB OF THE CATHETER CAME OFF AND THE TIP BROKE OFF IN THE 0.35 CATHETER. REPORTEDLY HE THEN REMOVED ALL OF THE DEVICES AND LEFT THE SHORT SHEATH IN PLACE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5897271 ↗