MAUDE Adverse Event Report: BIOTRACE MEDICAL INC. BIOTRACE TEMPO PACING LEAD; ELECTRODE, PACEMAKER, TEMPORARY

Lot Number 30583

Device Problems Material Separation (1562); Connection Problem (2900)

Patient Problem Complete Heart Block (2627)

Event Date 09/05/2018

Event Type  Injury  

Event Description

The patient had an alcohol septal ablation treatment of hocm.A temporary pacing catheter (bio trace tempo) had been placed prior to the procedure, as a precaution for anticipated av block.Following the procedure the patient was transported to the coronary care icu with the pacing catheter connected to an external pacemaker generator via a disposable remington medical cable (ref: (b)(4)).Approximately 36 hours post procedure, while still in the ccu, the patient was observed to go into complete heart block and the temporary pacemaker, which has been set on demand at a rate of 60 bpm did not prompt capture and cpr was started by the nurse attending to the pt.A second nurse then determined that the connecting cable had separated from the pacing lead and reconnected the lead to the cable, with prompt capture and the pt regained consciousness.A detailed review of the incident found that a contributing factor was that the adapter pins provided in the tempo lead packaging (also present in other temporary pacing leads packaging) were used to connect the cable, instead of simply attaching the shrouded leads pins directly into the cable.The use of adapter pins in this fashion extended the distance that the locking mechanism beyond its usable limit.Therefore the temporary lead and cable were not securely connected and the connection failed.Dates of use: (b)(6) 2018 - (b)(6) 2018.Diagnosis or reason for use: av block.

• Brand Name: BIOTRACE TEMPO PACING LEAD
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): BIOTRACE MEDICAL INC.
• MDR Report Key: 7910025
• MDR Text Key: 121991769
• Report Number: MW5080100
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/24/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Device Operator: Health Professional
• Device Expiration Date: 06/29/2019
• Device Lot Number: 30583
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/25/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention