PHENOM CATHETER
Report
- Report Number
- 2029214-2025-02293
- Event Type
- Malfunction
- Date Received
- October 28, 2025
- Date of Event
- October 21, 2025
- Report Date
- January 22, 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
- SZ
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
CONTINUATION OF D10: PRODUCT ID PED2-400-14 (B800024). 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.
B5 UPDATED WITH ADDITIONAL INFORMATION RECEIVED. D3, D4, H4 UPDATED WITH DEVICE INFORMATION RECEIVED. 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 : VISUAL INSPECTION/DAMAGE LOCATION DETAILS: THE DISTAL AND PROXIMAL DPS RESTRAINTS WERE INTACT. THE DPS SLEEVES WERE FOUND INTACT WITH NO SIGNS OF DAMAGE. THE DISTAL HYPOTUBE APPEARED STRETCHED, WITH THE PTFE SHRINK TUBING STILL INTACT. THE PIPELINE FLEX BRAID WAS FOUND DETACHED FROM THE PUSHWIRE AND STUCK INSIDE THE CATHETER LUMEN. THE DISTAL AND PROXIMAL ENDS OF THE BRAID WERE FOUND TO BE FULLY OPEN AND FRAYED. NO BENDS WERE FOUND WITH THE PUSHWIRE. NO DEFECTS WERE FOUND WITH THE TIP COIL, DISTAL MARKER, RE-SHEATHING MARKER, RE-SHEATHING PAD, OR PROXIMAL BUMPER. THE CATHETER TIP, MARKER, AND BODY WERE EXAMINED; NO DAMAGES WERE FOUND. THE CATHETER BODY WAS FOUND TO BE ACCORDIONED AT 7.0CM TO 12.4CM FROM THE DISTAL TIP. NO OTHER ANOMALIES WERE OBSERVED. TESTING/ANALYSIS: THE BRAID WAS THEN REMOVED FROM THE CATHETER WITH DIFFICULTY. THE TOTAL AND USABLE LENGTHS OF THE CATHETER WERE MEASURED TO BE WITHIN SPECIFICATIONS. THE CATHETER WAS FLUSHED WITH WATER AND FOUND PATENT. THE CATHETER WAS THEN TESTED BY RUNNING AN IN-HOUSE 0.026¿ MANDREL THROUGH THE CATHETER HUB WITHOUT ISSUE; RESISTANCE WAS OBSERVED AT THE DAMAGED LOCATIONS. CONCLUSION: BASED ON THE RETURNED DEVICES, THE CUSTOMER REPORTS OF "DEVICE OPENS PREMATURELY" AND "RESISTANCE DURING DELIVERY" WERE CONFIRMED, AS THE PIPELINE FLEX SHIELD BRAID WAS FOUND DETACHED FROM THE PUSHWIRE AND STUCK INSIDE THE CATHETER LUMEN. ADDITIONALLY, THE OBSERVED DAMAGE TO THE CATHETER (ACCORDIONING), BRAID (FRAYING), AND HYPOTUBE (STRETCHING) SUGGESTS THAT A HIGH FORCE WAS APPLIED. IT APPEARS THAT THESE DAMAGES MAY HAVE OCCURRED WHEN THE CUSTOMER ATTEMPTED TO RETRIEVE THE PIPELINE FLEX SHIELD THROUGH THE CATHETER, ENCOUNTERING RESISTANCE. POSSIBLE CAUSES OF THE RESISTANCE INCLUDE VESSEL TORTUOSITY AND A LACK OF CONTINUOUS FLUSH DURING THE PROCEDURE. THE CUSTOMER REPORTED THAT THE VESSEL TORTUOSITY WAS NORMAL AND THAT A CONTINUOUS FLUSH WAS USED, ELIMINATING THEM AS POTENTIAL CAUSES. THE CAUSE OF THE RESISTANCE COULD NOT BE DETERMINED. POSSIBLE CAUSES OF THE DEVICE OPENING PREMATURELY INCLUDE RESISTANCE DURING DELIVERY, EXCESSIVE FORCE DURING DELIVERY, OVER-MANIPULATION, OR ROTATING OR PULLING BACK THE PUSHWIRE DURING DEL IVERY. 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 REPORT THAT A PIPELINE FLEX WITH SHIELD COULD NOT BE RESHEATHED. IT WAS NOTED THAT IT SEEMED THE SLEEVES WERE STUCK, BLOCKING THE PHENOM 27 CATHETER. ADDITIONALLY, DURING DELIVERY OF THE PIPELINE TO THE DISTAL POINT, IT DEPLOYED IN THE MICROCATHETER. IT WAS NOTED THE PIPELINE AND ALL ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU) THE PIPELINE WAS NOT IMPLANTED; IT WAS REMOVED AND REPLACED TO COMPLETE THE PROCEDURE SUCCESSFULLY. OTHER ANCILLARY DEVICES INCLUDED: CEREGLIDE 71 GUIDE CATHETER, SYNCHRO STANDARD GUIDEWIRE THERE WAS NO HARM OR INJURY TO THE PATIENT WHO WAS UNDERGOING A PROCEDURE FOR FLOW DIVERSION TREATMENT OF A RIGHT INTERNAL CAROTID A RTERY (ICA) UNRUPTURED SACCULAR ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 9MM AND THE NECK DIAMETER WAS 5MM. VESSEL TORTUOSITY WAS NORMAL. DUAL ANTIPLATELET TREATMENT (DAPT) (ASPIRIN AND PLAVIX) WAS ADMINISTERED. ANGIOGRAPHIC RESULTS POST PROCEDURE WERE FINE.
ADDITIONAL INFORMATION RECEIVED REPORTED ONLY ONE PIPELINE WAS IN USE AT TIME OF THE REPORTED ISSUES. IT WAS CLARIFIED THAT FIRST THE PIPELINE COULD NOT BE RESHEATHED. AFTER REPEATED ATTEMPTS, THE PIPELINE WAS FINALLY RESHEATHED BUT DURING REPOSITIONING, THE PIPELINE DEPLOYED WITHIN THE MICROCATHETER. THE PIPELINE PUSHWIRE WAS NOT PULLED BACK OR ROTATED DURING THE PROCEDURE; FOR RESHEATHING, A COMBINATION BETWEEN PUSH AND PULL OF THE MICROCATHETER AND PUSHWIRE WAS USED. A CONTINUOUS CATHETER FLUSH WAS ADMINISTERED AND MAINTAINED PER THE IFU. THERE WAS NO VISIBLE DAMAGE TO THE CATHETER OR PIPELINE PUSHWIRE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1967091 | 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 | 65 YR | Female | SEE H11... |