MAUDE Adverse Event Report: ST. JUDE MEDICAL PACEL BIPOLAR PACING CATHETER; ELECTRODE, PACEMAKER, TEMPORARY

Model Number	401767
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	05/06/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
During a transcatheter aortic valve implantation (tavi) procedure, a perforation occurred with extraction of the leads.The patient was transferred to surgery for repair of the hole in the apex.No additional information is available at this time.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
During a transcatheter aortic valve implantation (tavi) procedure, a perforation occurred and the catheter was removed.An echocardiogram was performed along with a transesophageal echocardiography to diagnose the perforation.The patient was transferred to surgery for repair of the hole in the rv apex.The patient was stable after the thoracic surgery.There were no performance issues with the device.

• Brand Name: PACEL BIPOLAR PACING CATHETER
• Common Device Name: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): ST. JUDE MEDICAL; 14901 deveau place; minnetonka MN 55345 2126
• MDR Report Key: 8621735
• Report Number: 2182269-2019-00059
• Device Sequence Number: 2172919
• Product Code: LDF
• UDI-Device Identifier: 05414734001076
• UDI-Public: 05414734001076
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K875059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: 401767
• Device Catalogue Number: 401767
• Device Lot Number: 6741509
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/09/2019
• Supplement Date Received by Manufacturer: 05/21/2019
• Initial Report FDA Received Date: 05/17/2019
• Supplement Report FDA Received Date: 06/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention