STARTER GUIDEWIRE
Report
- Report Number
- 9681477-2021-00021
- Event Type
- Malfunction
- Date Received
- December 3, 2021
- Date of Event
- November 17, 2021
- Report Date
- March 2, 2022
- Manufacturer
- LAKE REGION MEDICAL LIMITED
- Product Code
- DQX
- UDI-DI
- 08714729743071
- PMA / PMN Number
- K935170
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
DISTRIBUTOR CONFIRMED DEVICE NOT AVAILABLE FOR RETURN.
UPDATED WITH DEVICE EVALUATION
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.
IT WAS REPORTED THAT: DOSSIER: MV 21-0540 DIFFICULTY IN PROGRESSING WITH THE GUIDE IN THE HUMERAL ARTERY. WHEN IT IS RELEASED, THE SHEATH WAS SEVERED. CLINICAL CONSEQUENCES OBSERVED: SECOND SURGICAL APPROACH.
IT WAS REPORTED THAT: -DOSSIER : MV 21-0540 DIFFICULTY IN PROGRESSING WITH THE GUIDE IN THE HUMERAL ARTERY. WHEN IT IS RELEASED, THE SHEATH WAS SEVERED. -CLINICAL CONSEQUENCES OBSERVED : SECOND SURGICAL APPROACH.
IT WAS REPORTED THAT: -DOSSIER : MV 21-0540 DIFFICULTY IN PROGRESSING WITH THE GUIDE IN THE HUMERAL ARTERY. WHEN IT IS RELEASED, THE SHEATH WAS SEVERED. -CLINICAL CONSEQUENCES OBSERVED : SECOND SURGICAL APPROACH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1824259 | STARTER GUIDEWIRE | GUIDEWIRE | DQX | LAKE REGION MEDICAL LIMITED | M001491211 | 6512321 | 08714729743071 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |