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

Model Number	401771
Medical Device Problem Code	Material Too Rigid or Stiff (1544)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	06/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
Two days post procedure, a right ventricle perforation was noted.During a transcatheter aortic valve implantation (tavi) procedure, the device was placed in the right ventricle.Two days following the procedure, the patient was transferred to the intensive care unit, where a right ventricle perforation was noted.The patient experienced rapid hypotension and a short cardiac arrest after the device was removed.An echocardiogram revealed a pericardial tamponade for which a pericardiocentesis was performed to stabilize the patient.The physician stated the pacing catheter felt hard following removal.
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.

• 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: 10282665
• Report Number: 2182269-2020-00062
• Device Sequence Number: 596684
• Product Code: LDF
• UDI-Device Identifier: 05414734001137
• UDI-Public: 05414734001137
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K152784
• 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): 08/22/2020

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: 02/28/2023
• Device Model Number: 401771
• Device Catalogue Number: 401771
• Device Lot Number: 7443703
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/18/2020
• Supplement Date Received by Manufacturer: 08/21/2020
• Initial Report FDA Received Date: 07/16/2020
• Supplement Report FDA Received Date: 08/22/2020
• 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