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

Model Number	020005
Medical Device Problem Code	No Pacing (3268)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/01/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Conclusion not yet available-evaluation in progress.
Event or Problem Description
The tb was placed on (b)(6) 2016.Stimulation was possible after electrode placement.Then broke off after a few hours.Have tried to reposition the electrode, but this did not give any improvement.The patient was then implanted with a permanent pacemaker.No permanent health damage occurred for the patient.With the oscor device was combined a pace 100.
Additional Manufacturer Narrative
The device was in use for treatment.A review of the device history record (dhr) was conducted and there were no manufacturing rejects or anomalies of this type recorded in the device history records.The device passed all in-process and qa final inspection steps before shipping to the customer.A complaint review of the reported lot found no additional reports.One 5f unshrouded temporary bipolar pacing lead was received back from the customer along with a non-oscor introducer sheath and contamination guard.There were no other accessories.No visible blood was found anywhere on the lead.The insulation was not cut, abraded or detached.The black and the red connectors were pulled away from their respective wires, leaving the shrink tubing exposed and the inner wires broken.The broken inner wires were confirmed via x-ray.The lead did not exhibit electrical activity when tested with a multi-meter.It is unknown if an extension cable was used or if the connectors were inserted directly into the external pacemaker.Returned device analysis reveals one 5f temporary bipolar pacing lead that incurred extensive physical damage in the field.Due to the condition in which the lead was received it is believed that this device may have been subjected to excessive forces and/or excessive manipulation in the field causing the red and black connector wires to fracture underneath the insulation.No manufacturing defects were found during analysis.Per tb lead inspection procedure temporary lead final inspection, the leads are inspected visually and tested for electrical continuity 100 percent by qa prior to shipping to the customer.The instructions for use (ifu) informs the user: avoid kinking or bending the lead to minimize the risk of damage to internal wires.Avoid subjecting the device to unusual stresses.A 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.The following section was corrected: device manufacture date is 02/15/2016.

• Brand Name: TB 5F TEMPORARY BIPOLAR PACING LEAD
• Common Device Name: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): OSCOR INC.; 3816 de soto blvd.; palm harbor FL 34683 1816
• MDR Report Key: 6229409
• Report Number: 1035166-2016-00197
• Device Sequence Number: 141846
• Product Code: LDF
• UDI-Device Identifier: 00836559009733
• UDI-Public: 00836559009733
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K861403
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2018

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
• Operator of Device: Physician
• Device Expiration Date: 03/01/2019
• Device Model Number: 020005
• Device Catalogue Number: 020005
• Device Lot Number: DP-04422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/30/2016
• Supplement Date Received by Manufacturer: 03/17/2017
• Initial Report FDA Received Date: 01/06/2017
• Supplement Report FDA Received Date: 06/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PACE 100; PACE 100