MAUDE Adverse Event Report: REMINGTON MEDICAL, INC. REMINGTON MEDICAL DISPOSABLE ADAPTER CABLE ADAP2000; CABLE, TRANSDUCER AND ELECTRODE PATIENT

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: REMINGTON MEDICAL DISPOSABLE ADAPTER CABLE ADAP2000
• Type of Device: CABLE, TRANSDUCER AND ELECTRODE PATIENT
• Manufacturer (Section D): REMINGTON MEDICAL, INC.
• MDR Report Key: 7910025
• MDR Text Key: 121991769
• Report Number: MW5080100
• Device Sequence Number: 2
• Product Code: DSA
• 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

• Date FDA Received: 09/25/2018
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• 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