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

Model Number 401771

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/15/2020

Event Type  malfunction  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event 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.

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 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
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): ST. JUDE MEDICAL; 14901 deveau place; minnetonka MN 55345 2126
• MDR Report Key: 10311062
• MDR Text Key: 199987791
• Report Number: 2182269-2020-00064
• Device Sequence Number: 1
• Product Code: LDF
• UDI-Device Identifier: 05414734001137
• UDI-Public: 05414734001137
• Combination Product (y/n): N
• PMA/PMN Number: K152784
• 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: 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 07/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1