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

Model Number	401762
Medical Device Problem Codes	Pacing Problem (1439); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	01/31/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Following a transcatheter aortic valve implantation procedure, in the evening the patient was brought in for a temporary lead implant with an external pacemaker.The patient was noted to be displaying bradycardia with a heartbeat of 38 beats/minute with lability.Following the procedure, the patient went into cardio-respiratory arrest and was sent for cardiac resuscitation.The patient was then recovered via cardiac massage.It was noted that the temporary lead had not been functioning.The external pacemaker and the lead cable were exchanged, and then the temporary lead was repositioned, but the temporary lead still only functioned intermittently.The temporary lead was noted to be fixed to the patient by being sutured to the skin.This was then determined to be the issue as the sutures were overtightened and caused the conductor to break and the catheter not to pace.The patient was implanted with a non-abbott single-chamber pacemaker on (b)(6) 2022 and was discharged on (b)(6) 2022 with no complications related to the cardio-respiratory arrest.
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 pacing issue and subsequent cardio-respiratory arrest could not be conclusively determined.
Additional Manufacturer Narrative
Additional information: g3, h2 (medical device problem code - 2017 - improper or incorrect procedure or method added).Corrected information: h2 (investigation conclusions), h10.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 was attributed to overtightening of the sutures by the user.

• 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: 13716862
• Report Number: 2182269-2022-00013
• Device Sequence Number: 14975034
• Product Code: LDF
• UDI-Device Identifier: 05414734001045
• UDI-Public: 05414734001045
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K161873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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
• Report Date (Section B): 03/10/2022

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: 11/30/2022
• Device Model Number: 401762
• Device Catalogue Number: 401762
• Device Lot Number: 8025213
• Was Device Available for Evaluation?: No
• 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: 03/10/2022
• Supplement Date Received by Manufacturer: 03/10/2022
• Initial Report FDA Received Date: 03/09/2022
• Supplement Report FDA Received Date: 03/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown