PHOENIX GUIDEWIRE
Report
- Report Number
- 9681477-2025-00118
- Event Type
- Injury
- Date Received
- October 29, 2025
- Date of Event
- October 8, 2025
- Report Date
- November 11, 2025
- Manufacturer
- LAKE REGION MEDICAL LIMITED
- Product Code
- DQX
- UDI-DI
- 10845225002760
- PMA / PMN Number
- K080144
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
NO DEVICE WAS RETURNED FOR ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE SPECIMEN DEVICE DOES NOT PRESENT ANY INDICATION OF MANUFACTURING DEFECT OR ANOMALY THAT COULD HAVE IMPACTED ON THE EVENT AS REPORTED. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. THE COMPLAINT IS NON-VERIFIABLE AS THE PRODUCT WAS NOT RETURNED FOR EVALUATION. AT THIS TIME, IT IS NOT POSSIBLE TO ASSIGN A DEFINITIVE ROOT CAUSE FOR THE EVENT AS REPORTED. BASED ON THE INFORMATION PROVIDED BY THE SUPPORTING DOCUMENTATION, "DEVICE INTERACTION", "IMPROPER HANDLING" AND/OR "UNDETERMINED CAUSE" APPEARS TO HAVE IMPACTED ON THE EVENT AS REPORTED. WITHOUT THE RETURN OF THE ACTUAL DEVICE IN QUESTION FOR EVALUATION, LAKE REGION MEDICAL IS UNABLE TO DETERMINE THE EXACT CAUSE FOR THIS INCIDENT. LAKE REGION MEDICAL HAS NO OPEN PREVENTATIVE ACTION SPECIFIC TO MANUFACTURING THIS PRODUCT DIFFERENTLY.
NO DEVICE WAS RETURNED FOR ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE SPECIMEN DEVICE DOES NOT PRESENT ANY INDICATION OF MANUFACTURING DEFECT OR ANOMALY THAT COULD HAVE IMPACTED ON THE EVENT AS REPORTED. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. THE COMPLAINT IS NON-VERIFIABLE AS THE PRODUCT WAS NOT RETURNED FOR EVALUATION. AT THIS TIME, IT IS NOT POSSIBLE TO ASSIGN A DEFINITIVE ROOT CAUSE FOR THE EVENT AS REPORTED. BASED ON THE INFORMATION PROVIDED BY THE SUPPORTING DOCUMENTATION, "DEVICE INTERACTION", "IMPROPER HANDLING" AND/OR "UNDETERMINED CAUSE" APPEARS TO HAVE IMPACTED ON THE EVENT AS REPORTED. WITHOUT THE RETURN OF THE ACTUAL DEVICE IN QUESTION FOR EVALUATION, LAKE REGION MEDICAL IS UNABLE TO DETERMINE THE EXACT CAUSE FOR THIS INCIDENT. LAKE REGION MEDICAL HAS NO OPEN PREVENTATIVE ACTION SPECIFIC TO MANUFACTURING THIS PRODUCT DIFFERENTLY.
HELLO NEW ROSS COMPLAINT HANDLING GROUP: WE HAVE RECEIVED A COMPLAINT FOR PHOENIX LIGHT SUPPORT GUIDEWIRE: PG14300LF, LOT: 7932023 WHERE THE DISTAL WIRE TIP BROKE. A SNARE WAS ATTEMPTED TO REMOVE THE BROKEN TIP BUT WAS UNSUCCESSFUL, THUS THE DISTAL TIP REMAINED IN THE LEFT FEMORAL ARTERY. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. PLEASE LET US KNOW IF YOU HAVE ANY FURTHER QUESTIONS. THANK YOU. COMPLAINT # (B)(4). DATE OF EVENT: 10/07/2025. PHILIPS REPORTABILITY AWARE DATE: 10/08/2025. COUNTRY: FRANCE (FRA). NATURE OF COMPLAINT: AT THE END OF THE PROCEDURE DURING THE RETRIEVAL OF THE PHOENIX CATHETER SYSTEM, THE GUIDE WIRE WAS BROKEN IN 2 PARTS. THE DISTAL PART REMAINED IN THE LEFT FEMORAL ARTERY. THE PRACTICIAN HAS TRIED TO CATCH IT WITH A SNARE BUT WITHOUT SUCCESS. DEVICE WILL NOT BE RETURNED. TYPE OF CASE: PERIPHERA.L ACCESS LOCATION: FEMORAL. VESSEL TORTUOSITY: SEVERE. PROCEDURE TYPE: THERAPEUTIC. WAS RESISTANCE ENCOUNTERED? NO. LESION CALCIFICATION: SEVERE. TYPE OF "TARGET" LESION: CALCIFIED. PERIPHERAL VESSEL: COMMON FEMORAL. VESSEL SEGMENT: PROX. ACCESS APPROACH: CONTRALATERAL. CHRONIC TOTAL OCCLUSION (CTO)? UNKNOWN. DID AN EMBOLIZATION OCCUR? YES. WAS THE SUPPORT CLIP USED? (PHOENIX CATHETER): YES.
HELLO NEW ROSS COMPLAINT HANDLING GROUP: WE HAVE RECEIVED A COMPLAINT FOR PHOENIX LIGHT SUPPORT GUIDEWIRE: PG14300LF, LOT 7932023 WHERE THE DISTAL WIRE TIP BROKE. A SNARE WAS ATTEMPTED TO REMOVE THE BROKEN TIP BUT WAS UNSUCCESSFUL, THUS THE DISTAL TIP REMAINED IN THE LEFT FEMORAL ARTERY. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. PLEASE LET US KNOW IF YOU HAVE ANY FURTHER QUESTIONS. THANK YOU. COMPLAINT # (B)(4) DATE OF EVENT: 10/07/2025. PHILIPS REPORTABILITY AWARE DATE: 10/08/2025. COUNTRY: FRANCE (FRA). NATURE OF COMPLAINT: AT THE END OF THE PROCEDURE DURING THE RETRIEVAL OF THE PHOENIX CATHETER SYSTEM, THE GUIDE WIRE WAS BROKEN IN 2 PARTS. THE DISTAL PART REMAINED IN THE LEFT FEMORAL ARTERY. THE PRACTICIAN HAS TRIED TO CATCH IT WITH A SNARE BUT WITHOUT SUCCESS. DEVICE WILL NOT BE RETURNED. TYPE OF CASE: PERIPHERAL. ACCESS LOCATION: FEMORAL. VESSEL TORTUOSITY: SEVERE. PROCEDURE TYPE: THERAPEUTIC. WAS RESISTANCE ENCOUNTERED? NO. LESION CALCIFICATION: SEVERE. TYPE OF "TARGET" LESION: CALCIFIED. PERIPHERAL VESSEL: COMMON FEMORAL. VESSEL SEGMENT: PROX. ACCESS APPROACH: CONTRALATERAL. CHRONIC TOTAL OCCLUSION (CTO)? UNKNOWN. DID AN EMBOLIZATION OCCUR? YES. WAS THE SUPPORT CLIP USED? (PHOENIX CATHETER): YES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 219392 | PHOENIX GUIDEWIRE | GUIDEWIRE, PRODUCT CODE: DQX | DQX | LAKE REGION MEDICAL LIMITED | OFG2524LF | 7932023 | 10845225002760 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |