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

Model Number 020005

Device Problem No Pacing (3268)

Patient Problem No Information (3190)

Event Date 03/28/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information has been requested, however not received as of date of this report.A preliminary review showed there were no manufacturing rejects or anomalies of this event type recorded in the device history record.Conclusion not yet available as the investigation is on-going.

Event Description

It was reported that the pacemaker probe did not stimulate and no impulses were given.Even after trying different changes in position, no action could be registered.Additional information has been requested but not received as yet.

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.There were no visual damages.Returned device analysis reveals one 5f temporary bipolar pacing lead with an appropriately functioning negative bipolar resistance (red pin to hull), and a positive bipolar resistance (black pin to tip) that did not measure to specifications.The red pin to hull measured at 14.5 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 first measured (the specification indicates this should measure at 10-20 ohms.The strain relief area was manipulated and the current registered at a variable rate.The strain relief was removed, and there was no visible damages seen below the strain relief.The molded portion was x-rayed to check for any damages in the wires internally.There were no breakages observed in the conductor wire when viewed on x-ray.Additional x-rays were taken on the other side of the molded hub, and on both edges of the molded hub.No damages were observed on the internal wires.Additionally, the entire length of the wire was x-rayed and viewed during live x-ray and there were no visible breakages along the length of the device.The black connector assembly was evaluated further to determine the direct cause of the electrical resistance fluctuations observed when the strain relief was manipulated.The connector was observed under x-ray and no breakages of the conductor wire could be identified.When the connector cap housing and heat shrink applied over the electrode pin and extruded wire cover were removed, it was identified that the conductor wire going to the black connector broke at the proximal opening of the electrode pin.Returned device analysis reveals one tb lead, 5f un-shrouded, with an appropriately functioning negative bipolar resistance, and a positive bipolar resistance that indicated variable rates when manipulating the strain relief area.X-ray imaging of the overmolded hub and connector assembly was performed but could not identify a break in the wires.After the black connector was disassembled it was identified that the conductor wire had fractured at the proximal opening of the electrode pin.The heat shrink assembled over the electrode pin and extruded wire cover prevented the connector from separating from the fractured wire and caused the fluctuations in the electrical resistance measurement observed when the strain relief was manipulated.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 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.

• 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: 7466499
• MDR Text Key: 107220289
• Report Number: 1035166-2018-00034
• Device Sequence Number: 1
• Product Code: LDF
• UDI-Device Identifier: 00836559009733
• UDI-Public: 00836559009733
• 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,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 09/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/01/2019
• Device Model Number: 020005
• Device Catalogue Number: 020005
• Device Lot Number: DP-05274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1