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

Model Number	401763
Medical Device Problem Code	Pacing Problem (1439)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During the temporary pacemaker implantation procedure, the device was unable to pace.In the catherization laboratory due to sinus bradycardia, it was noted that the surgeon routinely operated the product and was unable to pace the heart rhythm during the procedure.The product was replaced to complete the procedure with no adverse patient consequences.
Additional Manufacturer Narrative
One 5f pacel bipolar pacing catheter (flow direct) was received for analysis.Electrical testing revealed an open circuit between the ring electrode and the proximal (+) connector pin, consistent with the reported event.The open circuit was isolated to the bifurcation.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the open circuit remains unknown.
Additional Manufacturer Narrative
The results of the investigation concluded there was an open circuit between the ¿(+)¿ proximal pin and the ring electrode consistent with the reported event.Additional investigation revealed a fractured wire within the bifurcation.The cause of the open circuit is consistent with the wire fracture.

• Brand Name: PACEL FLOW DIRECTED PACING CATHETER
• Common Device Name: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): ST. JUDE MEDICAL; 14901 deveau place; minnetonka MN 55345 2126
• Manufacturer (Section G): ST. JUDE MEDICAL; 14901 deveau place; minnetonka MN 55345 2126
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15545240
• Report Number: 2182269-2022-00041
• Device Sequence Number: 5685119
• Product Code: LDF
• UDI-Device Identifier: 05414734007856
• UDI-Public: 05414734007856
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K161873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/18/2022

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: 07/31/2023
• Device Model Number: 401763
• Device Catalogue Number: 401763
• Device Lot Number: 8330079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2022
• Supplement Date Received by Manufacturer: 10/26/2022; 12/14/2022
• Initial Report FDA Received Date: 10/05/2022
• Supplement Report FDA Received Date: 11/01/2022; 12/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown