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	Cardiac Perforation (2513)
Date of Event	04/01/2019
Type of Reportable Event	Serious Injury
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.The pacel instructions for use (ifu) states that cardiac perforation, cardiac tamponade and damage to vessels/valve structures are possible complications that may occur when using the product.Furthermore, the instructions for use (ifu) states that potential adverse effects may be associated with the pacel bipolar pacing catheter.These include arrhythmias, cardiac perforation, cardiac tamponade, and damage to vessel or valve structures.
Event or Problem Description
The catheter wire perforated the heart wall.A 6f lead was used without a balloon.The procedure was aborted and the patient was transferred to another hospital for surgical intervention.A patch was placed on the perforated part of the heart.The patient is stable.

• 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: 8528553
• Report Number: 2182269-2019-00036
• Device Sequence Number: 1840322
• Product Code: LDF
• UDI-Device Identifier: 05414734001076
• UDI-Public: 05414734001076
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Report Date (Section B): 04/18/2019

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: 08/31/2020
• Device Model Number: 401767
• Device Catalogue Number: 401767
• Device Lot Number: 6129490
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2019
• Initial Report FDA Received Date: 04/18/2019
• 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: Required Intervention