MAUDE Adverse Event Report: OSCOR INC. TB TEMPORARY PACING LEAD CONVENIENCE KIT; TEMPORARY PACEMAKER ELECTRODE

Model Number TBK06110USG

Device Problems Bent (1059); Disconnection (1171)

Patient Problem Cardiac Arrest (1762)

Event Date 02/20/2016

Event Type  Injury  

Manufacturer Narrative

The device was in use for treatment.One 6f unshrouded temporary bipolar pacing lead was received back from the customer with a contamination guard covering a portion of the lead.There were no other accessories.No visible blood was found on the lead.An analysis of the returned device reveals one 6f temporary bipolar pacing lead that incurred extensive physical damage in the field.Electrical testing was performed for continuity and resistance.The continuity test passed, meaning the device had an open circuit as intended.The resistance testing of the anode (hull electrode) and the cathode (tip electrode) failed the resistance test with erratic resistance reading in the mega ohm range.Visual observations: the first thing that was observed was the bent pin on the red connector.After cutting off the un-shrouded pin caps it was found that both connectors had detached from the crimped pin.The electrical resistance test was performed again without connectors and passed, thus confirming the detached connectors were causing the large resistance measurements.A review of the device history record identified no manufacturing rejects or anomalies.This device is subject to 100% visual and electrical testing at the manufacture.The 6f temporary bipolar pacing lead passed all in-process and qa final inspection steps before shipping to the customer including electrical, dimensional and visual inspection.Based on the condition of the returned device, it may have been subjected to a large amount of force at the time of use in order to bend the pin while the device was implanted in the patient.The stress put on the connector would have been more than enough to detach the connectors from the wire.Once the wires become detached the resistance through the lead becomes very high and erratic which affects the accuracy of the signals to and from the pacemaker potentially causing the problem experienced by the user.The investigation was inconclusive based on the information available and condition of the returned device.

Event Description

The customer reported that during use of the tb lead that there was a sudden onset of pacing failure; no pacing spikes were identified and the patient went into cardiac arrest two times.The user further reported that as there was no signal, they started checking all connections and found that one of the pins was bent.

• Brand Name: TB TEMPORARY PACING LEAD CONVENIENCE KIT
• Type of Device: TEMPORARY PACEMAKER ELECTRODE
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683 1618
• Manufacturer (Section G): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683 1618
• Manufacturer Contact: jan flegeau ; 3816 desoto blvd.; palm harbor, FL 34683-1618 ; 7279372511
• MDR Report Key: 5525016
• MDR Text Key: 41117957
• Report Number: 1035166-2016-00031
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• PMA/PMN Number: K861403
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 09/01/2018
• Device Model Number: TBK06110USG
• Device Catalogue Number: TBK06110USG
• Device Lot Number: DP-03724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 90 YR