PHENOM CATHETER
Report
- Report Number
- 9617601-2025-03608
- Event Type
- Malfunction
- Date Received
- December 18, 2025
- Date of Event
- December 16, 2025
- Report Date
- March 26, 2026
- Manufacturer
- MEDTRONIC MEXICO S. DE R.L. DE CV
- Product Code
- QJP
- UDI-DI
- 00763000276188
- PMA / PMN Number
- K180959
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
CONTINUATION OF D10: PIPELINE FLEX WITH SHIELD TECHNOLOGY STENT PRODUCT ID: PED2-400-16, (LOT D062778); MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
H6: FDD A0406 WAS INCORRECTLY SUBMITTED AND SHOULD BE A0512. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
H3 PRODUCT ANALYSIS: AS FOUND CONDITION: THE PIPELINE FLEX SHIELD BRAID AND PHENOM 27 RETURNED FOR ANALYSIS WITHIN SHIPPING BOX; WITHIN AN OPENED PIPELINE FLEX SHIELD OUTER CARTON AND INNER POUCH; AND WITHIN A DISPENSER COIL. THE PIPELINE FLEX SHIELD PUSHWIRE WAS NOT RETURNED FOR ANALYSIS. THEREFORE, ANY CONTRIBUTING FACTORS COULD NOT BE ASSESSED. HOWEVER, THE PIPELINE FLEX SHIELD BRAID WAS RETURNED STUCK WITHIN CATHETER HUB. THE PIPELINE FLEX SHIELD BRAID WAS STUCK INSIDE THE CATHETER. DAMAGE LOCATION DETAILS: THE DISTAL AND PROXIMAL ENDS OF PIPELINE FLEX SHIELD WERE FOUND FULLY OPENED AND DAMAGED. NO FLASH OR VOIDS MOLDED WERE OBSERVED IN THE HUB. THE CATHETER BODY WAS FOUND TO BE KINKED AT ~83.0CM AND ~87.3CM FROM PROXIMAL END. THE CATHETER TIP AND MARKER BAND WERE EXAMINED; AND NO DAMAGE WAS FOUND. NO OTHER ANOMALIES WERE OBSERVED. TESTING/ANALYSIS: THE TOTAL AND USABLE LENGTHS OF THE CATHETER WERE MEASURED TO BE WITHIN SPECIFICATIONS. THE CATHETER WAS CUT TO REMOVE THE BRAID FROM THE CATHETER LUMEN. THE CATHETER WAS FLUSHED WITH WATER AND WATER EXITED OUT FROM THE DISTAL TIP. THE CATHETER WAS THEN TESTED BY RUNNING AN IN-HOUSE 0.0265¿ MANDREL THROUGH CATHETER TIP AND HUB. THE MANDREL SUCCESSFULLY PASSED THROUGH THE CATHETER HUB AND TIP WITH NO ISSUES; HOWEVER, THE RESISTANCE OBSERVED AT THE DAMAGED LOCATIONS. CONCLUSION: BASED ON THE ANALYSIS FINDINGS, THE PIPELINE FLEX SHIELD WAS CONFIRMED TO HAVE RESISTANCE DURING RETRIEVAL AND RE-SHEATHING AS THE BRAID WAS RETURNED STUCK INSIDE THE CATHETER. POSSIBLE CAUSES INCLUDE DAMAGED CATHETER, BURRS, BUMPS, KINKS OR OTHER DAMAGE ON PED OR PUSHWIRE, FRAYED ENDS ON BRAID, PATIENT VESSEL TORTUOSITY, USER DOES NOT MAINTAIN CONTINUOUS FLUSH, AND USERS PULLS BACK ON/TORQUES WIRE WHILE ADVANCING PED IN MICROCATHETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE AND THE CATHETER WAS CONTINUOUSLY FLUSHED WITH HEPARINIZED SALINE. WHICH ELIMINATES THESE FACTORS OUT AS POTENTIAL CAUSES. THE PIPELINE FLEX SHIELD COULD NOT BE CONFIRMED TO HAVE PUSHWIRE BREAK/SEPARATION AS THE PUSHWIRE WAS NOT RETURNED FOR ANALYSIS, ANY CONTRIBUTION OF THE PUSHWIRE TOWARDS THE RESISTANCE AND PUSHWIRE BREAK/SEPARATION COULD NOT BE ASSESSED. HOWEVER, THE ROOT CAUSE COULD NOT BE DETERMINED. ADDITIONALLY, THE PIPELINE FLEX SHIELD AND PHENOM 27 COULD NOT BE CONFIRMED TO HAVE RESISTANCE AT HUB AND STUCK IN CATHETER HUB AS NO RESISTANCE WAS OBSERVED DURING TESTING. NO DEFECT WAS FOUND WITH CATHETER HUB. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
MEDTRONIC RECEIVED A REPORT THAT AFTER THE START OF THE RELEASE OF THE PIPELINE FLEX WITH SHIELD TECHNOLOGY STENT, IT WAS OBSERVED THAT IT WAS NOT PROPERLY POSITIONED. IT WAS NECESSARY TO RECAP (RESHEATH) AND AT THAT MOMENT THE ENTIRE SYSTEM WENT DOWN, REQUIRING THE WHOLE SYSTEM TO BE RESTARTED. THE PIPELINE GOT STUCK INSIDE THE HUB OF THE PHENOM 27 MICROCATHETER DURING RESHEATHING. THE PHYSICIAN RELEASED THE LOAD (SLACK) IN THE SYSTEM IN AN ATTEMPT TO RESOLVE THE ISSUE, HOWEVER IT DID NOT RESOLVE THE ISSUE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING DENSE MESH FLOW DIVERSION SURGERY FOR TREATMENT OF AN UNRUPTURED, SACCULAR, LEFT INTERNAL CAROTID ARTERY ANEURYSM WITH A MAX DIAMETER OF 6.2 MM AND A 4 MM NECK DIAMETER. THE LANDING ZONE ARTERIAL DIAMETER WAS 3.82 MM DISTALLY AND 4 MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. RIGHT FEMORAL ARTERY ACCESS VESSEL DIAMETER WAS 3 MM. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS REPORTED AS SATISFACTORY. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED, AND THE CATHETER WAS FLUSHED, AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PIPELINE WAS USED FOR AN APPROVED INDICATION (ON-LABEL). THERE WAS NO DAMAGE TO THE CATHETER, HOWEVER, THE DISTAL PUSHWIRE WAS DAMAGED. THE THREAD BROKE AFTER THE DOCTOR'S MANIPULATION. THE CATHETER WAS CONTINUOUSLY FLUSHED WITH HEPARINIZED SALINE. ANCILLARY DEVICES INCLUDED: NEURON MAXX 90 CM SHEATH, 5F SOFIA 115CM GUIDECATHETER.
ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PROCEDURE WAS PERFORMED VIA THE RIGHT FEMORAL ARTERY. WHEN A PRODUCT WAS REPLACED TO COMPLETE THE PROCEDURE, ANOTHER PIPELINE DEVICE WAS USED. THE PHRASE "THE ENTIRE SYSTEM WENT DOWN, REQUIRING THE WHOLE SYSTEM TO BE RESTARTED" REFERS TO THE TRIAXIAL SYSTEM PLUMMETING DUE TO THE PATIENT¿S ANATOMICAL TORTUOSITY. RESISTANCE OCCURRED SPECIFICALLY WHEN POSITIONING THE PIPELINE, BUT THERE WAS NO RESISTANCE WHEN PULLING THE STENT BACK TO THE DISTAL END OR TIP OF THE CATHETER, THROUGH THE CATHETER TOWARDS THE HUB, IN THE CENTER, OR INSIDE THE PIPELINE SHEATH. NO RESISTANCE OR DIFFICULTY WAS ENCOUNTERED DURING DELIVERY. THE CAUSE OF RESISTANCE WAS IDENTIFIED AS TENSION IN THE SYSTEM DURING RECAPPING OF THE PIPELINE. THE CAUSE OF THE PUSH WIRE BREAKAGE WAS NOT DETERMINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2172260 | PHENOM CATHETER | CATHETER, PERCUTANEOUS, NEUROVASCULATURE | QJP | MEDTRONIC MEXICO S. DE R.L. DE CV | FG15160-0615-1S | 231763116 | 00763000276188 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | SEE H11... |