PROCURE ENDOMYOCARDIAL BIOPSY FORCEPS
Received May 28, 2021 · Event occurred Apr 28, 2021
Report 3005334138-2021-00327 · MDR key 11900308
Device
Generic name
Device, Biopsy, Endomyocardial
Manufacturer
St. Jude MedicalModel number
408296Catalog number
408296
Lot number
9941140
Product problems
- Mechanical Problem
- Mechanical Problem
Patient
60 YR
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
RELATED MANUFACTURER REPORT NUMBER: 3005334138-2021-00328. DURING THE BIOPSY OF RV MYOCARDIAL TISSUE, THE JAWS ON THE FORCEPS WOULD NOT CLOSE. THE DEVICE WAS REPLACED, BUT THE SAME ISSUE OCCURRED WITH THE SECOND DEVICE. THE CASE WAS UNABLE TO BE COMPLETED DUE TO THIS ISSUE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: G3, G6, H2, H3, H6 THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AS SUPPORTED BY THE RECEIVING INSPECTION RESULTS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.