MAUDE Adverse Event Report: OSCOR INC ATAR D-IS1 2PACE DISPOSABLE EXTENSION CABLE; CABLE, ELECTRODE

Model Number ATAR D-IS1-2PACE

Device Problem Connection Problem (2900)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/20/2017

Event Type  malfunction  

Manufacturer Narrative

The conclusion is not yet available, the evaluation is in process.This initial mdr is being submitted to meet our requirements of reporting.A follow-up will be submitted as soon as the investigation is complete.

Event Description

The set screw on the is-1 receptacle portion of the extension did not engage as intended.On 5/8/2017 the following additional information was received from the customer: what is the outcome of the patient? had to open a permanent generator to pace the patient.No impact to the patient/ patient stable? yes, delay in care.Was there any adverse effect to the patient? no.Was there any extended hospitalization? no.What procedure the product was used for? temporary pacer.

Manufacturer Narrative

A review of device history record (dhr) was conducted and there were no manufacturing rejects or anomalies recorded in the dhr affecting released product.The released device passed all in-process and qa final inspection steps including mechanical, dimensional and electrical tests before shipping to the customer.A complaint review of the reported lot found no additional reports involving this lot number.The receptacles were inspected per processes contained in bipolar is-1 receptacle assembly in-process and final inspection.The atar instructions for use (ifu) instructs the user that the extension cable is intended to connect an electrode/lead from a patient or another cable to a diagnostic machine or an external pacemaker.It cautions the user prior to use, to read all package inserts, warnings, precautions, and instructions.Failure to do so may result in severe patient injury or death.Three atar d-is-1-2pace adaptors from the reported lot number were returned from the customer.There were no other accessories.No visible blood was found on any of the adaptors.Upon evaluation of the returned product, it was found that two of the adaptors had the set screw backed out too far.The screw was not engaged with the set screw block.The remaining adaptor had an excessive chamfer on the threaded side hole that affects the function of the set screw.When the set screw is backed out (counterclockwise) there is minimal thread engagement which inhibits the set screw from being tightened.The silicone was removed from above the set screws for further inspection of the threaded component.It was identified that the component has an excessive chamfer on the threaded side hole which affects the function of the set screw.When the set screw is backed out (counterclockwise) there is minimal thread engagement which inhibits the set screw from being tightened.An additional existing control point that was reviewed during the investigation is the qa final inspection of the finished adaptor per "bipolar lead adaptors/extensions final inspections" procedure.All final production units are functionally tested for set screw engagement.The final production test is performed by inserting a "transportation pin" which simulates the final lead connection and secures the screw during transportation.The screw is set to hold the transportation pin and test the screw process.An opportunity was identified to improve this functional inspection using a torque limiting tool.With this method, the screw force applied can be standardized between final inspection and simulate end user application.This improvement will further enhance the detectability of this failure mode.The device was to be used for treatment.The device was returned for analysis and the investigation determined that the reason for the return was confirmed as the set screws did not function properly.Corrective and preventive actions were implemented.No further action is required.The event will be re-evaluated if additional information becomes available.

Manufacturer Narrative

The reported lot was recalled under report number 1035166-06/01/2017-01-r in june 2017 for a different product issue.

• Brand Name: ATAR D-IS1 2PACE DISPOSABLE EXTENSION CABLE
• Type of Device: CABLE, ELECTRODE
• Manufacturer (Section D): OSCOR INC; 3816 desoto blvd; palm harbor FL 34683 1816
• MDR Report Key: 6649052
• MDR Text Key: 77842720
• Report Number: 1035166-2017-00049
• Device Sequence Number: 1
• Product Code: IKD
• UDI-Device Identifier: 00885672102074
• UDI-Public: 00885672102074
• Combination Product (y/n): N
• PMA/PMN Number: K070926
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 06/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/01/2020
• Device Model Number: ATAR D-IS1-2PACE
• Device Catalogue Number: ATAR D-IS1-2PACE
• Device Lot Number: C3-17388
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/26/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1035166-06/01/2017-01-R
• Patient Sequence Number: 1
• Treatment: PERMANENT GENERATOR