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

Model Number 408296

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/28/2021

Event Type  malfunction  

Event Description

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.

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.

• Brand Name: PROCURE ENDOMYOCARDIAL BIOPSY FORCEPS
• Type of Device: DEVICE, BIOPSY, ENDOMYOCARDIAL
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 11900308
• MDR Text Key: 256170154
• Report Number: 3005334138-2021-00327
• Device Sequence Number: 1
• Product Code: DWZ
• Combination Product (y/n): N
• PMA/PMN Number: K991486
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: 408296
• Device Catalogue Number: 408296
• Device Lot Number: 9941140
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/06/2021
• Initial Date FDA Received: 05/28/2021
• Supplement Dates Manufacturer Received: 06/15/2021
• Supplement Dates FDA Received: 06/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PROCURE FORCEPS
• Patient Age: 60 YR