PHENOM CATHETER
Report
- Report Number
- 9617601-2025-03211
- Event Type
- Malfunction
- Date Received
- December 5, 2025
- Date of Event
- November 27, 2025
- Report Date
- February 23, 2026
- Manufacturer
- MEDTRONIC MEXICO S. DE R.L. DE CV
- Product Code
- QJP
- UDI-DI
- 00763000304317
- PMA / PMN Number
- K151638
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PL
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
CONTINUATION OF D10: PRODUCT ID: PED2-500-25 (D023092). 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 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: EQUIPMENT USED: VIDEO INSPECTION SYSTEM (M-85519), RULER (M-83361), CAMERA (PANASONIC LUMIX DMC-ZS5), IN-HOUSE 0.026IN MANDREL AS FOUND CONDITION: THE PIPELINE FLEX SHIELD BRAID WAS RETURNED STUCK INSIDE THE PHENOM 27 CATHETER, WITHIN THE OUTER CARTON, BIO-HAZARD BAG, AND SHIPPING BOX. THE PUSHWIRE WAS NOT RETURNED. DAMAGE LOCATION DETAILS: THE DISTAL END OF THE BRAID WAS NOT OPEN AND FRAYED. THE PROXIMAL END OF THE BRAID WAS FOUND TO BE OPEN AND FRAYED. THE CATHETER TIP AND MARKER WERE EXAMINED, WITH NO DAMAGE FOUND. HOWEVER, THE CATHETER BODY WAS FOUND TO BE FLATTENED BETWEEN 11.0 CM TO 13.0CM FROM THE DISTAL TIP. NO OTHER ANOMALIES WERE OBSERVED. TESTING/ANALYSIS: THE CATHETER WAS CUT TO REMOVE THE BRAID. THE TOTAL AND USABLE LENGTH WERE MEASURED WITHIN SPECIFICATIONS. THE CATHETER WAS FLUSHED WITH WATER AND FOUND TO BE PATENT. IT WAS THEN TESTED BY RUNNING AN IN-HOUSE 0.026¿ MANDREL THROUGH THE CATHETER HUB WITHOUT ISSUE; HOWEVER, THE RESISTANCE WAS OBSERVED AT THE DAMAGED LOCATION. CONCLUSION: BASED ON THE RETURNED DEVICES, THE CUSTOMER REPORT OF "FAILURE TO OPEN AT THE DISTAL END" WAS CONFIRMED, AS THE BRAID'S DISTAL END WAS NOT OPEN AND FRAYED. THE CAUSE OF THE FAILURE TO OPEN COULD NOT BE DETERMINED. POSSIBLE CAUSES FOR THIS FAILURE INCLUDE VESSEL TORTUOSITY, A DAMAGED BRAID, OR DEPLOYMENT OF THE BRAID IN A VESSEL BEND. THE CUSTOMER REPORTED THAT THE VESSEL TORTUOSITY WAS MODERATE AND THAT THE BRAID WAS NOT POSITIONED IN THE VESSEL BENDS, RULING OUT THESE FACTORS AS POTENTIAL CAUSES. IT IS POSSIBLE THAT THE DAMAGE TO THE BRAID CONTRIBUTED TO THE FAILURE TO OPEN. SUCH DAMAGE CAN OCCUR DUE TO OVER-MANIPULATION, IMPROPER DEPLOYMENT TECHNIQUE, OR RESISTANCE ENCOUNTERED WHEN ADVANCING OR RETRACTING THE DELIVERY WIRE, AS WELL AS DURING DEPLOYMENT OR RE-SHEATHING AGAINST RESISTANCE. ADDITIONALLY, THE CUSTOMER'S REPORT OF "RESISTANCE DURING RETRIEVAL" WAS CONFIRMED, AS DAMAGE WAS FOUND ON BOTH THE PIPELINE FLEX SHIELD BRAID AND THE PHENOM 27 CATHETER. THE OBSERVED DAMAGE TO THE CATHETER (FLATTENING) AND BRAID (FRAYING), INDICATES THAT HIGH FORCE WAS APPLIED. THIS DAMAGE MAY HAVE RESULTED FROM THE CUSTOMER'S ATTEMPTS TO RETRIEVE THE PIPELINE FLEX SHIELD THROUGH THE CATHETER WHILE ENCOUNTERING RESISTANCE. POSSIBLE CAUSES OF RESISTANCE INCLUDE VESSEL TORTUOSITY AND A LACK OF CONTINUOUS FLUSHING WITH HEPARINIZED SALINE DURING THE PROCEDURE. THE CUSTOMER INDICATED THAT THE VESSEL'S TORTUOSITY WAS MODERATE, AND A CONTINUOUS FLUSH WAS USED DURING DELIVERY, RULING THEM OUT AS POTENTIAL CAUSES. THE CAUSE OF THE RESISTANCE COULD NOT BE DETERMINED. H6. CODING UPDATED BASED ON ANALYSIS FINDINGS. 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 INFORMATION REGARDING A PIPELINE SHIELD STENT THAT FAILED TO OPEN AT THE DISTAL END AND WAS STUCK IN THE PHENOM 27 MICROCATHETER DURING RETRIEVAL. THE PATIENT WAS UNDERGOING A PROCEDURE FOR FLOW DIVERTER TREATMENT OF A RIGHT INTERNAL CAROTID ARTERY (R-ICA) UNRUPTURED SACCULAR ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 8.5MM AND THE NECK DIAMETER WAS 5MM. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. PATIENT'S VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE DEVICES WERE PREPARED AND CATHETER FLUSHED CONTINUOUSLY WITH HEPARINIZED SALINE AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PHENOM 27 WAS NAVIGATED IN PLACE WITH THE GUIDEWIRE. AN ATTEMPT WAS MADE TO DEPLOY THE PIPELINE SHIELD BUT THE STENT FAILED TO OPEN AT THE DISTAL END. IT WAS NOTED THAT LESS THAN 50% OF THE PIPELINE WAS DEPLOYED WHEN THE FAILURE TO OPEN OCCURRED. THE PIPELINE WAS NOT POSITIONED IN A BEND. FULL WALL APPOSITION WAS NOT ACHIEVED. THE PIPELINE WAS RESHEATHED 2 OR LESS TIMES. BALLOON ANGIOPLASTY WAS NOT USED. NO OTHER STEPS OR DEVICES WERE USED TO OPEN THE PIPELINE. DURING RETRIEVAL, THE PIPELINE WAS STUCK IN THE MIDDLE SEGMENT OF THE MICROCATHETER. THE SYSTEM WAS REMOVED TOGETHER. BOTH DEVICES WERE REPLACED WITH ANOTHER MANUFACTURER'S DEVICES TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO HARM OR INJURY TO THE PATIENT ASSOCIATED WITH THIS EVENT. ANCILLARY DEVICE: RIST 7F 105CM GUIDE CATHETER.
ADDITIONAL INFORMATION RECEIVED THAT NO DAMAGE TO THE PIPELINE PUSHWIRE OR CATHETER WAS OBSERVED. THE CAUSE OF THE PIPELINE FAILURE TO OPEN WAS NOT DETERMINED. THE CAUSE OF THE RESISTANCE DURING PIPELINE RETRIEVAL WAS NOT DETERMINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2854630 | PHENOM CATHETER | CATHETER, PERCUTANEOUS, NEUROVASCULATURE | QJP | MEDTRONIC MEXICO S. DE R.L. DE CV | FG15150-0615-1S | 231688436 | 00763000304317 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Female | SEE H11. |