MAUDE Adverse Event Report: OSCOR INC. TB 5F TEMPORARY BIPOLAR PACING LEAD; ELECTRODE, PACEMAKER, TEMPORARY

Model Number 020023

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/09/2018

Event Type  malfunction  

Manufacturer Narrative

Conclusion not yet available as the investigation is on-going.A follow-up will be submitted as soon as the investigation is complete.

Event Description

It was reported that for the stimulation of a patient the hospital connected the tb temporary pacemaker lead to an external pacemaker, but was not able to stimulate the patient.After checking the cable they recognized that the cable was broken near to the end of the black connector.They replaced the temporary pacing lead with a new one and could finish the procedure without any problems.The patient is stable and not injured.

Manufacturer Narrative

The device history records were reviewed to confirm that the device passed all applicable in-process and final inspections.One 5f unshrouded temporary bipolar pacing lead was received back from the customer.There were no other accessories.No visible blood was found anywhere on the lead.Upon initial evaluation of the returned lead, it was observed that the black connector was broken off completely with only a small piece of shrink tubing holding the connector to the wire.The red connector was completely intact.When measured with a multimeter, it was found that the positive bipolar resistance (red pin to hull) was within manufacturing specification but the negative bipolar resistance (black pin to tip) did not register an electrical value.The red pin to hull measured 13.3 ohms, which met the requirement of 10-20 ohms, as set in final inspection procedures.The black pin to tip did not register a current when measured (the specification indicates this should measure 10-20 ohms.Returned device analysis reveals one tb lead, 5f un-shrouded, with an appropriately functioning negative bipolar resistance and a positive bipolar resistance that did not register a current when tested with a multimeter.The black connector pin was no longer attached to the wire which resulted in no electrical functionality.Capa was previously opened to investigate the root cause and to implement corrective action to prevent recurrence of this issue.The event will be re-evaluated if additional information becomes available.Oscor will continue to monitor this event type and risk.Field action has been initiated for tb lead.The tb leads are inspected visually and tested for electrical continuity 100% by qa prior to shipping to the customer per procedure temporary lead final inspection (model tb).The instructions for use (ifu) is provided with this device.Per the ifu, the precautions state, avoid kinking or bending the lead to minimize the risk of damage to internal wires.Oscor inc.Is submitting the above report to comply with 21 cfr part 803, the medical device reporting regulation.The report is based upon information obtained by oscor inc.Which the company may not have been able to investigate or verify prior to the date the report was required by fda.This report does not constitute an admission that the device, oscor inc., or its employees, caused or contributed to the event described in this report.Nor does this report reflect a conclusion by fda, oscor inc., or its employees, that the report constitutes an admission that the device, oscor inc., or its employees caused or contributed to the event described in this report.

• Brand Name: TB 5F TEMPORARY BIPOLAR PACING LEAD
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683 1816
• MDR Report Key: 7843265
• MDR Text Key: 119503453
• Report Number: 1035166-2018-00081
• Device Sequence Number: 1
• Product Code: LDF
• UDI-Device Identifier: 00083655900991
• UDI-Public: 0083655900991
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 10/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2020
• Device Model Number: 020023
• Device Catalogue Number: 020023
• Device Lot Number: DP-05418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2018
• Initial Date Manufacturer Received: 08/21/2018
• Initial Date FDA Received: 09/04/2018
• Supplement Dates Manufacturer Received: 09/10/2018
• Supplement Dates FDA Received: 10/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1035166-09/07/2018-01-R
• Patient Sequence Number: 1