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

Model Number	408296
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/13/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Endomyocardial biopsy forceps did not open properly during biopsy procedure, requiring a new forceps to be used.No harm to the pt.

• Brand Name: ST JUDE PROCURE ENDOMYOCARDIAL BIOPSY FORCEPS 7F
• Common Device Name: FORCEPS / BIOPSY
• Manufacturer (Section D): ST JUDE / ABBOTT LABORATORIES; plymouth MN 55442
• MDR Report Key: 7742740
• Report Number: MW5078789
• Device Sequence Number: 1258966
• Product Code: KGE
• UDI-Device Identifier: 05415067009548
• UDI-Public: (01)05415067009548
• 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: 07/31/2020
• Device Model Number: 408296
• Device Catalogue Number: 408296
• Device Lot Number: 9915399
• 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: 56 YR
• Patient Weight: 117