PhenomTM 21 CatheterRecalls & reported problems across all models

We found 4 models of PhenomTM 21 Catheter by Micro Therapeutics, Inc. in the FDA's device registry (GUDID). Together they are named in 25 adverse event reports in the FDA's MAUDE database, received between Nov 19, 2020 and May 6, 2026 — classified as 1 death, 7 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (16 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported PhenomTM 21 Catheter problems

PhenomTM 21 Catheter models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• PhenomTM 21 Catheter FG13160-0615-1S

  Catheter, continuous flush
  1 death10 reports
• PhenomTM 21 Catheter FG13150-0615-2S

  Catheter, continuous flush
  7 reports
• PhenomTM 21 Catheter FG13160-0615-1S

  Catheter, continuous flush
  7 reports
• PhenomTM 21 Catheter FG13150-0615-2S

  Catheter, percutaneous
  1 report

Recent PhenomTM 21 Catheter adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2026Retraction Problem

  MEDTRONIC RECEIVED A REPORT OF TWO PIPELINE VANTAGE DEVICES THAT FAILED TO OPEN. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN AMORPHOUS, UNRUPTURED ANEURYSM LOCATED IN THE BASILAR ARTERY WITH A MAX DIAMETER OF 4.3MM AND A 5.3MM NECK DIAMETER. THE LANDING ZONE (ARTERY SIZE) WAS 1.3MM DISTAL AND 1.8MM PROXIMAL. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. DAPT (DUAL ANTIPLATELET TREATMENT ) WAS ADMINISTERED WITH AN UNKNOWN PLATELET REACTIVITY UNITS (PRU) LEVEL. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS NONE. THERE ARE IMAGES AVAILABLE FOR REVIEW. IT WAS REPORTED THAT DURING FLOW-DIVERTING STENT IMPLANTATION FOR AN ANEURYSM, THE ANEURYSM WAS A FUSIFORM ANEURYSM LOCATED IN THE P2 SEGMENT. THE INTERMEDIATE CATHETER WAS IN PLACE, AND THE MICROCATHETER WAS POSITIONED APPROPRIATELY. A 250-14 STENT WAS SELECTED. AFTER DELIVERING THE STENT TO THE TARGET POSITION, THE TIP END OF THE STENT FAILED TO OPEN PROPERLY. DESPITE CONTINUED DEPLOYMENT, THE STENT REMAINED ROD-SHAPED. IT WAS RETRIEVED AND REDEPLOYED THREE TIMES IN AN ATTEMPT TO ACHIEVE OPENING, BUT IT STILL FAILED TO OPEN. THE MICROCATHETER AND STENT WERE REPLACED AND THE REPLACEMENTS WERE ADVANCED TO THE TARGET P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25104551 ↗
• MalfunctionApr 20, 2026Retraction Problem

  NO NEW EVENT INFORMATION. PHENOM 21 MICROCATHETER DEVICE INFORMATION PROVIDED THAT THE LOT NUMBER WAS 231520626.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24933041 ↗
• InjuryDec 29, 2025Retraction Problem; Physical Resistance/Sticking; Retraction Problem; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING THAT THE PATIENT DID HAVE CLIPPING BECAUSE THE PIPELINE TREATMENT FAILED EVEN THOUGH IT WAS PREVIOUSLY REPORTED THAT THERE WERE NO FUTURE PLANS FOR MEDICAL OR SURGICAL INTERVENTIONS FOR THE ANEURYSM AND NO MEDICAL OR SURGICAL INTERVENTIONS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23916983 ↗
• InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT THERE WAS DISTAL EMBOLIZATION IN THE SAME TERRITORY DURING PROCEDURE, CAUSED BY FRAGMENTATION OF THE CLOTH DURING THROMBECTOMY. THE EVENT RESULTED IN HOSPITALIZATION AND HAD A CAUSAL RELATIONSHIP TO THE STENT AND PROCEDURE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE EMBOLISM WAS IN THE CEREBRAL ARTERY. ADDITIONAL INFORMATION RECEIVED INDICATED THE CAUSE OF THE CLOT FRAGMENTATION WAS THE MECHANICAL THROMBECTOMY. THE INITIAL LOCATION OF THE CLOT BEING TREATED WAS THE MIDDLE CEREBRAL ARTERY (MCA) M2 SEGMENT. THE PATIENT VESSEL TORTUOSITY AND WHETHER THE DEVICE(S) WERE PREPARED PER THE INSTRUCTIONS FOR USE (IFU) WAS NOT COLLECTED IN THE CLINICAL TRIAL. NO ADDITIONAL ACTION WAS TAKEN IN ORDER TO RESOLVE THE EVENT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE EVENT RECOVERED/RESOLVED THE SAME DAY ON (B)(6) 2020. THE EVENT WAS ASSESSED TO BE NOT RELATED TO THE STENT RETRIEVER. ADDITIONAL INFORMATION RECEIVED REPORTED THE CLINICAL EVENT COMMITTEE (CEC) ADJUDICATED ASSESSMENT OF THIS EVENT WITH THE CONCLUSION THE DISTAL EMBOLIZATION EVENT HAD A CAUSAL RELATIONSHIP TO THE STUDY PROCEDURE AND COULD POSSIBLY BE RELATED TOTHE SOLITAIRE DEVICE AND/OR

  Patient problems: Thromboembolism

  MAUDE report 23653423 ↗
• InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THERE WAS EMBOLIZATION OF PART OF THE RETRIEVED CLOT DURING RETRIEVAL. THERE WAS OCCLUSION OF THE FRONTO LATERAL RIGHT M3 SEGMENT. NIHSS WAS 12. THE ISSUE WAS RESOLVED WITH SEQUELAE ON 2021-SEP-04. THE ADVERSE EVENT WAS NOT RELATED TO THE DISEASE UNDER STUDY. THE ADVERSE EVENT WAS NOT RELATED TO THE UNDERLYING CONDITION OR DISEASE. THE ADVERSE EVENT WAS CASUALLY RELATED TO THE PROCEDURE AND DEVICE. THE SPONSOR ASSESSMENT REPORTED THE ADVERSE EVENT HAD A CASUAL RELATIONSHIP TO THE PROCEDURE AND WAS POSSIBLY RELATED TO THE REACT AND SOLITAIRE DEVICES. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A MIDDLE CEREBRAL ARTERY (MCA) CLOT, M2 IN THE RIGHT HEMISPHERE. THE PRE-PROCEDURE MTICI SCORE WAS 2B AND THE FINAL POST-PROCEDURE MTICI SCORE WAS 2B. ADDITIONAL INFORMATION WAS RECEIVED UPDATING THE PRE-PROCEDURE MTICI SCORE TO 0. IN ADDITION, IT WAS INDICATED THE EVENT WAS NOT RELATED TO THE RIPTIDE SYSTEM. ADDITIONAL INFORMATION WAS RECEIVED CLARIFYING THE EVENT AS DISTAL CEREBRAL ARTERY EMBOLISM. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT'S BASELINE MRS WAS 1. ADDITIONAL INFORMATION WAS RECEIVED. THE SPONSOR ASSESSMENT WAS UPDATED INDICATING TH

  Patient problems: Embolism/Embolus

  MAUDE report 23650376 ↗
• MalfunctionNov 12, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT AFTER DEPLOYMENT OF THE PIPELINE VANTAGE WITH SHIELD TECHNOLOGY STENT, RESISTANCE WAS MET WHEN ADVANCING THE PHENOM 27 MICROCATHETER ALONG THE PIPELINE DEVICE WIRE, AND THE WIRE COULD NOT BE FURTHER DRAWN INTO THE CATHETER STARTING FROM THE SECTION WITH THE PTFE SLEEVES, RESULTING IN TENSION. THE PUSHWIRE/CAPTURE COIL STUCK DURING RETRACTION AFTER THE PTFE SLEEVES ENTERED THE CATHETER. THE STENT WAS IMPLANTED AND THE CATHETER AND WIRE/TIP COIL WERE REMOVED FROM THE PATIENT. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED WITH THIS EVENT. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PIPELINE WAS USED FOR AN APPROVED INDICATION (ON-LABEL). THE PUSHWIRE WAS NOT ROTATED DURING REMOVAL. IT IS UNKNOWN IF THERE WAS ANY DAMAGE TO THE CATHETER, PUSHWIRE, OR CAPTURE COIL. ANCILLARY DEVICES INCLUDE A 150 CM PHENOM 27 MICROCATHETER. THE PATIENT IS ALIVE AND THERE WERE NO PATIENT COMPLICATIONS ASSOCIATED WITH THIS EVENT. THE LESION CHARACTERISTIC WAS AN INTERNAL CAROTID ARTERY. VESSEL TORTUOSITY WAS MODERATE. THE CATHETER WAS FLUSHED PER IFU DURING THE PROCEDURE. THERE WAS NO FRICTION OR DIFFI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23535668 ↗
• MalfunctionOct 15, 2025Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED. THE CAUSE OF THE EVENT WAS NOT DETERMINED. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY; HOWEVER, THE DEVICE COULD NOT BE RESHEATHED TO REPOSITION. ADDITIONALLY, IT WAS CLARIFIED THAT THE THIRD ATTEMPT AT TREATMENT WAS SUCCESSFUL WITH THE PHENOM 027 AND PIPELINE SHIELD, NOT WITH VANTAGE AS PREVIOUSLY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23294176 ↗
• MalfunctionJul 11, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT FOR MIDDLE CEREBRAL ARTERY (MCA) ISCHEMIC CEREBRAL (IC) INFARCTION. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE PATIENT'S PRE-OPERATIVE TICI SCORE WAS 1, AND THE POST-OPERATIVE TICI SCORE IMPROVED TO 2B. THE PATIENT WAS TREATED WITH A THROMBECTOMY PROCEDURE USING A TPS (THROMBECTOMY PLATFORM SYSTEM). THE SOLITAIRE DEVICE WAS USED, WITH ZERO PASSES PERFORMED DURING THE PROCEDURE. THE TIME REQUIRED FROM THE ONSET OF CEREBRAL INFARCTION TO REVASCULARIZATION/REVASCULARIZE WAS 30 MINUTES. IT WAS REPORTED THAT THE PHENOM 21 AND SOLITAIRE WERE SELECTED. THE DEGREE OF VASCULAR TORTUOSITY LEADING TO THE MCA WAS MODERATE. THE OPTIMO 9FR WAS DELIVERED TO THE IC, AND THE PHENOM 21 WAS PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE CHIKAI 14 WIRE, WHICH WAS ALSO PREPARED ACCORDING TO THE IFU, WAS SET UP. AFTER DELIVERING THE PHENOM 21 TO THE OCCLUSION SITE, AN ATTEMPT WAS MADE TO DELIVER THE SOLITAIRE STENT, WHICH HAD BEEN PREPARED ACCORDING TO THE IFU, INTO THE PHENOM 21. HOWEVER, STRONG RESISTANCE AND STIFFNESS WERE FELT. DESPITE SENSING ABNORMALITIES IN BOTH THE PHENOM 21 AND THE SOLITAIR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22486207 ↗
• MalfunctionMay 16, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT A SOLITAIREX6-40 ENCOUNTERED RESISTANCE IN THE DISTAL SHAFT OF THE PHENOM. STENT DISCONNECTION WAS ALSO NOTED AS THE SOLITAIRE DELIVERY PUSHER BECAME DISCONNECTED WHEN IT WAS PULLED INTO THE PHENOM OUTSIDE THE BODY. THE PATIENT WAS UNDERGOING THROMBECTOMY FOR TREATMENT OF AN ISCHEMIC CEREBRAL INFARCTION IN THE RIGHT M1. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE ACCESS VESSEL WAS THE MIDDLE CEREBRAL ARTERY (MCA)/INTERNAL CAROTID ARTERY (ICA) WITH A 2-5MM DIAMETER. TICI (POSTOPERATIVE): NO PROBLEMS. THE PATIENT WAS TREATED WITH A TPS. THERE WERE 2 PASSES FOR THE SOLITAIRE. TIME REQUIRED FROM ONSET OF CEREBRAL INFARCTION TO REVASCULARIZATION/REVASCULARIZE WAS ABOUT 1 HOUR. IT WAS REPORTED THAT AFTER THE PRODUCT WAS DEPLOYED TO THE RIGHT M1 AND SUCCESSFUL REVASCULARIZATION WAS ACHIEVED, IT WAS DEPLOYED AT THE OCCLUSION OF THE RIGHT ICA AND THE SOLITAIREX WAS COLLECTED INTO THE PHENOM 21. HOWEVER, WHEN THE SOLITAIREX WAS ABOUT HALFWAY INSERTED INTO THE PHENOM 21, IT BECAME IMPOSSIBLE TO RETRACT IT. DURING SURGERY, IT WAS COLLECTED AS IS AND THE PROCEDURE WAS COMPLETED, BUT WHEN IT WAS PULLED INTO THE PHENOM 21 OUTSIDE THE BODY, THE S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22035949 ↗
• InjuryApr 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT A PATIENT TREATED WITH A PED3 PIPELINE STENT AND PHENOM 21 CATHETER HAD STROKES. PATIENT UNDERWENT IMPLANTATION OF PIPELINE VANTAGE 3.5X16 ON (B)(6) 2024, WITHOUT COMPLICATIONS DURING THE PROCEDURE. ON (B)(6), SHE FAINTED AND WAS TAKEN TO HOSPITAL. THE DIAGNOSTIC INVESTIGATION REVEALED A HEMORRHAGIC STROKE. ON THE SAME DAY, SHE SUFFERED AN ISCHEMIC STROKE. ANGIOGRAPHY WAS CARRIED OUT WHILE SHE WAS IN HOSPITAL. HOSPITALIZATION AND SHOWED SEVERE HYPERPLASIA IN THE PIPELINE, RESULTING IN A STENOSIS OF 80/90% STENOSIS IN THE M1 SEGMENT OF THE LEFT MIDDLE CEREBRAL ARTERY. THE PATIENT UNDERWENT TREATMENT AND WAS DISCHARGED FROM HOSPITAL WITHOUT MOTOR DEFICITS ON (B)(6) 2025. THE PATIENT SUFFERED A HEMORRHAGIC STROKE 3 MONTHS AFTER THE VANTAGE PIPELINE WAS IMPLANTED, AND SOON AFTER, AN ISCHEMIC STROKE. IN THE INVESTIGATION, AN ANGIOGRAPHY WAS PERFORMED AND SHOWED A SEVERE HYPERPLASIA IN THE AREA WHERE THE PIPELINE WAS IMPLANTED, WITH ARTERIAL STENOSIS OF 80/90%. THE PATIENT RECEIVED DRUG TREATMENT TO CONTROL HYPERPLASIA. THE PATIENT WAS HOSPITALIZED FOR 12 DAYS AFTER THE HEMORRHAGIC STROKE. THERE WAS PERMANENT INJURY. SEVERE STENOSIS OF THE LEFT MIDDLE

  Patient problems: Hemorrhagic Stroke; Hyperplasia; Ischemia Stroke; Stenosis; Syncope/Fainting

  MAUDE report 21810969 ↗
• MalfunctionApr 2, 2025Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THE CAUSE WAS THE TORTUOUS ANATOMY WAS DUE TO THE CURVES, WHICH DID NOT ALLOW FOR THE DELIVERY OF THE DEVICE. WHEN THEY REMOVED THE MICROCATHETER WITH THE DIVERTER INSIDE, THEY MANIPULATED IT ON THE WORKBENCH, AND IT COULD BE PUSHED AND RECAPTURED (BUT ON THE WORKBENCH, WE DID NOT HAVE THE CURVES OR TENSIONS TO WHICH IT WAS EXPOSED IN THE PATIENT'S VASCULAR ANATOMY. RESISTANCE WAS FELT IN THE DISTAL PORTION AT THE TIME OF RELEASING THE DIVERTER; IT DID NOT RESPOND AND MOVED AS A BLOCK WHEN UNSHEATHING OR PUSHING THE DIVERTER'S PUSHER. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. EACH CATHETER HAD ITS HEPARINIZED IRRIGATION WITH AN INFUSER. DAMAGE TO THE PIPELINE PUSHWIRE OR CATHETER WAS OBSERVED, BUT IT WAS DUE TO THE FORCE OR TENSION APPLIED TO THE PUSHER WHEN TRYING TO ADVANCE THEDEVICE, NOT BEFORE ITS USE. THE DEVICE DID NOT JUMP DURING DEPLOYMENT. THE TIP OF THE CATHETER DID NOT MOVE DURING DEPLOYMENT. AFTER EXPOSING THE DISTAL COIL OF THE PUSHER, IT DID NOT RESPOND AND EVERYTHING MOVED AS A BLOCK. THE FLOW DIVERTER COULD NOT BE EXTERNALIZED OUT OF THE MICROCATHETER; IT NEVER EXITED THE MICROCATHETER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21753996 ↗
• MalfunctionSep 11, 2024Difficult to Advance; Unintended Movement; Difficult to Advance; Unintended Movement

  MEDTRONIC RECEIVED A REPORT THAT A PHENOM ENCOUNTERED MOVEMENT DURING PLACEMENT OF THE PIPELINE (DIFFICULT PLACEMENT/POSITIONING) THE REPORTED DEVICE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTION FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR A RUPTURED RIGHT MCA ANEURYSM WITH A BLISTER MORPHOLOGY. ANEURYSM DIMENSIONS: MAX AND NECK DIAMETER N/A. LANDING ZONE (ARTERY SIZE): DISTAL 2.59 MM AND PROXIMAL 2.74 MM. THE PATIENT¿S VESSEL TORTUOSITY WAS MINIMAL. THE PHYSICIAN WAS TREATING A RUPTURED RIGHT MCA BIFURCATION BLISTER ANEURYSM VIA THIS PIPELINE VANTAGE FD. THEY USED CEREBASE DA LONG SHEATH <(>&<)> PHENOM PLUS DAC AS ACCESS PRODUCTS. THEN THEY TOOK PHENOM-21 MICROCATHETER OVER HYBRID-12/14 GUIDEWIRE TO PLACE IT DISTALLY IN RIGHT INFERIOR MCA BRANCH. AFTER PLACING PHENOM-21, THEY STARTED PUSHING THIS PIPELINE VANTAGE FD. WHEN THIS FD STARTED COMING IN RIGHT M1, PHENOM-21 STARTED COMING BACK RAPIDLY. PHYSICIAN PUSHED PHENOM PLUS TILL ICA BIFURCATION AND PHENOM-21 MORE DISTALLY. AGAIN THEY TRIED TO PUSH THIS PIPELINE VANTAGE AND THIS TIME IT REACHED TILL DISTAL MARKER OF PHENOM-21. AFTER OPENING APPX. 4-5MM OF FD, ENTIRE SYSTEM OF PHENOM PLUS, PHENOM-21 AND TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20191625 ↗
• MalfunctionMay 21, 2024Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT A PED3 PIPELINE WAS STUCK IN A PHENON 21 CATHETER. THE PATIENT WAS UNDERGOING ANEURYSM EMBOLIZATION WITH A FLOW DIVERTER PIPELINE. DURING THE PASSAGE OF THE FIRST STENT IN THE PHENOM 21 CATHETER THE PASSAGE WAS OBSERVED TO BE BLOCKED, MAKING IT IMPOSSIBLE TO CONTINUE PROGRESSION IN THE CATHETER. IT WAS COMPLETELY LOCKED IN THE CATHETER MAKING IT IMPOSSIBLE TO BE REMOVED EVEN USING EXTRA FORCE. IT WAS DECIDED TO REMOVE THE CATHETER AND STENT. THE PROCEDURE WAS RESTARTED WITH A NEW PHENOM 21 CATHETER AND STENT IF THE SAME SIZE WITH PERFECT PASSAGE WITHOUT FRICTION. THE CATHETER RESISTANCE WAS IN THE MIDDLE OF THE CATHETER. THE CATHETER WAS DAMAGED IN THE MIDDLE SECTION. THE PUSHWIRE WAS NOT DAMAGED. THE DEIVCES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED, SACCULAR ANUERYSM IN THE ACM LOCATION. HE MAX DIAMETER WAS 4MM AND THE NECK DIAMETER WAS 7MM. THE DISTAL LANDING ZONE WAS 2.3MM AND THE PROXIMAL LANDING ZONE WAS 2.2MM. VESSEL TORTUOSITY WAS NORMAL. THE ACCESS VESSEL DIAMETER WAS 2.5MM. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19364600 ↗
• MalfunctionMar 14, 2024Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE SOLITAIRE X EXPERIENCED RESISTANCE AT THE PHENOM 21 MICROCATHETER HUB DURING PREPARATION. THEY TRIED SEVERAL TIMES SLOWLY, BUT THE DEVICE COULD NOT ENTER THE CATHETER. THE SOLITAIRE WAS DAMAGED IN THE PHENOM CATHETER HUB, AND THE HUB OF THE CATHETER WAS CRACKED. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ADDITIONAL INFORMATION WAS RECEIVED. IT WAS CLARIFIED THAT THE DISTAL PART OF SOLITAIRE WAS DAMAGED. FOR THE CAUSE OF THE EVENT IT WAS REPORTED THAT, "WE GUESS IT'S A PHENOM PROBLEM."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18909431 ↗
• MalfunctionAug 31, 2023Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED THAT CATHETER DELAMINATION OCCURRED DURING IN-HOUSE SIMULATED USE BENCHTOP TESTING. CATHETER DELAMINATION WAS OBSERVED DURING IN-HOUSE BENCHTOP TESTING BY MEDTRONIC ENGINEERS. THERE WERE NO PATENTS OR HCPS INVOLVED IN THE EVENT. THERE WERE NO KINKS ON THE PUSHWIRES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17667555 ↗

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