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

Model Number	401771
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
Four days following the placement of the temporary electrode, the proximal leg wire of the device broke requiring the device to be replaced.The patient's treatment was completed with the replacement device and the patient was released.
Additional Manufacturer Narrative
Because the reported catheter was not returned, investigation was limited to visual inspection of a photograph received from the event report.The leg wire appeared to be exposed and detached from the catheter assembly.Visual inspection was based solely upon a review of the photographs provided.The device was not returned.Additional investigation revealed the braided wire separated from the leg wire tube and the braided wire appears to be fractured close to the bifurcation cap.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event remains unknown.
Event or Problem Description
One day after the placement of the temporary electrode, the proximal leg wire of the device broke requiring the device to be replaced.The patient's treatment was completed with the replacement device and the patient was released.

• 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: 10311062
• Report Number: 2182269-2020-00064
• Device Sequence Number: 824881
• Product Code: LDF
• UDI-Device Identifier: 05414734001137
• UDI-Public: 05414734001137
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 07/29/2020

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: 10/31/2022
• Device Model Number: 401771
• Device Catalogue Number: 401771
• Device Lot Number: 7269362
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/22/2020
• Supplement Date Received by Manufacturer: 07/24/2020
• Initial Report FDA Received Date: 07/22/2020
• Supplement Report FDA Received Date: 07/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1