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

Model Number	408298
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/12/2018
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: FORCEPS, BIOPSY
• Manufacturer (Section D): ST. JUDE MEDICAL / ABBOTT LABORATORIES; plymouth MN 55442
• MDR Report Key: 7742702
• Report Number: MW5078788
• Device Sequence Number: 1705905
• Product Code: DWZ
• UDI-Device Identifier: 05415067009562
• UDI-Public: (01)05415067009562
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/30/2018

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 71