BIOTRACE TEMPO PACING LEAD

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-25 for BIOTRACE TEMPO PACING LEAD manufactured by Biotrace Medical Inc..

Event Text Entries

[121991769] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5080100
• MDR Report Key: 7910025
• Date Received: 2018-09-25
• Date of Report: 2018-09-24
• Date of Event: 2018-09-05
• Date Added to Maude: 2018-09-26
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 0
• Product Problem Flag: 0
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Sequence Number: 1

• Brand Name: BIOTRACE TEMPO PACING LEAD
• Generic Name: ELECTRODE, PACEMAKER, TEMPORARY
• Product Code: LDF
• Date Received: 2018-09-25
• Lot Number: 30583
• Device Expiration Date: 2019-06-29
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BIOTRACE MEDICAL INC.

Device Sequence Number: 2

• Brand Name: REMINGTON MEDICAL DISPOSABLE ADAPTER CABLE ADAP2000
• Generic Name: CABLE, TRANSDUCER AND ELECTRODE PATIENT
• Product Code: DSA
• Date Received: 2018-09-25
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: REMINGTON MEDICAL, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention	2018-09-25