MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PERI-GUARD; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

The device was not returned, and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported from an anonymous survey result that the potential patient adverse reaction for frequency of patch rupture/tear with use of peri-guard when used as a prosthesis for intra-cardiac and great vessel repair was rated moderate.The physician reported ¿post-op¿ (no further details).At the time of this report, no further detail was provided regarding if hospitalization was required, treatment for the event or the patient¿s outcome.No additional information is available.

Manufacturer Narrative

Additional information, b5: upon follow up it was reported that there was no rupture or tear; therefore, the peri-guard product is no longer considered suspect product in this event.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PERI-GUARD
• Type of Device: PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10515148
• MDR Text Key: 206342943
• Report Number: 1416980-2020-05588
• Device Sequence Number: 1
• Product Code: DXZ
• Combination Product (y/n): Y
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other