MAUDE Adverse Event Report: ST. JUDE MEDICAL / ABBOTT LABORATORIES PROCURE ENDOMYOCARDIAL BIOPSY FORCEPS 7F; FORCEPS, BIOPSY

Model Number 408298

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/12/2018

Event Type  malfunction  

Event Description

The biopsy forceps stopped working in the middle of a heart biopsy procedure.Required a new forceps to be used.No harm to the pt.

• Brand Name: PROCURE ENDOMYOCARDIAL BIOPSY FORCEPS 7F
• Type of Device: FORCEPS, BIOPSY
• Manufacturer (Section D): ST. JUDE MEDICAL / ABBOTT LABORATORIES; plymouth MN 55442
• MDR Report Key: 7742702
• MDR Text Key: 115988883
• Report Number: MW5078788
• Device Sequence Number: 1
• Product Code: DWZ
• UDI-Device Identifier: 05415067009562
• UDI-Public: (01)05415067009562
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: 408298
• Device Catalogue Number: 408298
• Device Lot Number: 9915655
• Was Device Available for Evaluation?: Yes
• 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 Age: 70 YR
• Patient Weight: 71