MAUDE Adverse Event Report: ST. JUDE MEDICAL PROCURE ENDOMYOCARDIAL BIOPSY FORCEPS; DEVICE, BIOPSY, ENDOMYOCARDIAL

Model Number 408296

Device Problem Difficult to Open or Close (2921)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/11/2020

Event Type  malfunction  

Event Description

During a myocardial biopsy the endomyocardial biopsy forceps failed to open on the third biopsy.Fda safety report id# (b)(4).

• Brand Name: PROCURE ENDOMYOCARDIAL BIOPSY FORCEPS
• Type of Device: DEVICE, BIOPSY, ENDOMYOCARDIAL
• Manufacturer (Section D): ST. JUDE MEDICAL; plymouth MN 55442
• MDR Report Key: 10448256
• MDR Text Key: 204421965
• Report Number: MW5096230
• Device Sequence Number: 1
• Product Code: DWZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: 408296
• Device Catalogue Number: 408296
• Device Lot Number: 9917304
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 42 YR
• Patient Weight: 65