PHENOM CATHETER
Report
- Report Number
- 9617601-2026-01494
- Event Type
- Malfunction
- Date Received
- February 27, 2026
- Date of Event
- February 15, 2026
- Report Date
- February 27, 2026
- Manufacturer
- MEDTRONIC MEXICO S. DE R.L. DE CV
- Product Code
- QJP
- UDI-DI
- 00763000304294
- PMA / PMN Number
- K151638
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
CONTINUATION OF D10: PRODUCT ID PED3-021-350-20 (LOT: D050452); IMPLANT DATE N/A; EXPLANT DATE N/A PRODUCT ID PED3-021-350-25 (LOT: B717131); IMPLANT DATE N/A; EXPLANT DATE N/A PRODUCT ID PED3-021-300-20 (LOT: D043019); IMPLANT DATE N/A; EXPLANT DATE N/A PRODUCT ID PED3-021-300-14 (LOT: B631125); IMPLANT DATE N/A; EXPLANT DATE N/A PRODUCT ID PED3-021-300-12 (LOT: B551608);IMPLANT DATE N/A; EXPLANT DATE N/A PRODUCT ID PED3-021-300-14 (LOT: B631125); IMPLANT DATE N/A; EXPLANT DATE N/A PRODUCT ID PED3-021-325-20 (LOT: B787131); IMPLANT DATE N/A; EXPLANT DATE N/A PRODUCT ID PED3-021-350-12 (LOT: B808099); IMPLANT DATE N/A; EXPLANT DATE N/A PRODUCT ID PED3-021-350-16 (LOT: D027551); IMPLANT DATE N/A; EXPLANT DATE N/A PRODUCT ID PED3-021-325-14 (LOT: B812490); IMPLANT DATE N/A; EXPLANT DATE N/A PRODUCT ID PED3-021-325-16 (LOT: D039142); IMPLANT DATE N/A; EXPLANT DATE N/A. 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 PHENOM 21 MICROCATHETER THAT HAD RESISTANCE DURING RETRIEVAL OF THE GUIDEWIRE. THE PATIENT WAS UNDERGOING A PROCEDURE FOR TELESCOPING OF AT LEAST 10 PIPELINE VANTAGE EMBOLIZATION DEVICE STENTS TO TREAT A BASILAR ARTERY UNRUPTURED FUSIFORM ANEURYSM. PATIENT'S VESSEL TORTUOSITY WAS NORMAL. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. IT WAS REPORTED THAT THE DEVICES WERE PREPARED AND CATHETER FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). DURING THE PROCEDURE, THE DOCTOR WANTED TO REMOVE THE GUIDEWIRE BY PULLING IT INTO THE PHENOM MICROCATHETER BUT COULD NOT DO SO; THERE WAS RESISTANCE AT THE DISTAL END OF THE PHENOM 21 MICROCATHETER. ADJUSTMENT OF THE CATHETER AND GUIDEWIRE WAS ATTEMPTED BUT THE ISSUE WAS NOT RESOLVED. THE SYSTEM WAS REMOVED TOGETHER AND THE PHENOM MICROCATHETER WAS NOTED TO HAVE ACCORDION-TYPE DAMAGE. THE MICROCATHETER WAS REPLACED WITH ANOTHER PHENOM 21 MICROCATHETER AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO HARM OR INJURY TO THE PATIENT ASSOCIATED WITH THIS EVENT; POST PROCEDURE ANGIOGRAPHY SHOWED VERY GOOD RESULTS. ANCILLARY DEVICES: SYNCHRO GUIDEWIRE, SOFIA 5F GUIDE CATHETER, PIPELINE VANTAGE WITH SHIELD EMBOLIZATION DEVICES (PED3-021-350-20 LOT: D050452 , PED3-021-350-25 LOT: B717131, PED3-021-300-20 LOT: D043019, PED3-021-300-14 LOT: B631125, PED3-021-300-12 LOT: B551608, PED3-021-300-14 LOT: B631125, PED3-021-325-20 LOT: B787131, PED3-021-350-12 LOT: B808099, PED3-021-350-16 LOT: D027551 , PED3-021-325-14 LOT: B812490, PED3-021-325-16 LOT: D039142).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 619079 | PHENOM CATHETER | CATHETER, PERCUTANEOUS, NEUROVASCULATURE | QJP | MEDTRONIC MEXICO S. DE R.L. DE CV | FG13150-0615-2S | 231868661 | 00763000304294 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Female | SEE H11. |