MAUDE Adverse Event Report: OSCOR INC. ATAR D-A, DARK BLUE DISPOSABLE; CABLE, ELECTRODE

Model Number ATAR D-A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 08/13/2018

Event Type  malfunction  

Manufacturer Narrative

The device was in use for treatment.The user noted that the patient death is related to a patient condition.The pacer had nothing to do with it.The device was not returned and there was no specific performance related failure reported by the user.The lot number of this device was not provided, therefore a review of the device history record or complaint history could not be performed.Inspection procedures require any oscor product to pass all in-process and qa final inspections before shipping to the customer.Per quality assurance atar cable in process and final inspection procedure: in process inspection, inspect 100% for continuity.A) connect black shrouded pin and black pin receptacle to the multimeter and verify continuity is present.The reading shall be less than 2.0 ohms.The multimeter display should be steady, not erratic.B) repeat the same for the red shrouded pin and red pin receptacle.In final inspection, inspect 100% for continuity.A) connect black shrouded pin and black pin receptacle to the multimeter and verify continuity is present.The reading shall be less than 2.0 ohms.The multimeter display should be steady, not erratic.B) repeat the same for the red shrouded pin and red pin receptacle.Per instructions for use (ifu) it cautions the user: prior to use, read all package inserts, warnings, precautions, and instructions.Failure to do so may result in severe patient injury or death.Do not connect any cable model to a/c power source; connection of exposed pins to a/c power source may pose a risk of serious injury or death.Extension cables are not intended for use with apnea monitors.The directions for use state: first attach the proximal connector(s) to a pacemaker/analyzer or another extension cable while observing polarity indicated by the color.Then attach the distal connector(s) to the temporary lead connector or to another extension cable, again observing polarity by the color.The detachment of the connection should be done in the reverse order.

Event Description

It was reported the hospital was having issues with our atar cables not staying connected to their transvenous pacing leads and myocardial pacing wires.They are having trouble with leads pulling out from the distal end of the atar cables after the receptacle connector is tightened down.They stated that it has happened several times and sometimes in emergency situations where the nursing staff have gloves on and possibly blood which may affect their ability to tighten down the connector.They said they have had multiple issues where they lost capture/pacing several times in critical patients due to connection issues.The reporter was not able to get the brand/models of the temporary transvenous pacing leads (cath lab) or the temporary pacing wires (cvor) currently used by the hospital.Per the hospital, the device model number is atar d-a.On 13-sep-2018 additional information was received the patient had expired on (b)(6) 2018.During cath procedure patient coded.It was related to patient condition; the pacer had nothing to do with it.The hospital does not have the lot number, and the device is not available for evaluation.They reported this is not a one-time incident.It's not the wire pulling out.The nursing staff have gloves on and possibly blood which may affect their ability to tighten down the connector.

Manufacturer Narrative

Additional testing was conducted on devices from lot number d2-06140 as below focusing on the connector of the device.Repeat connector retention testing on the female collapsing pin end on atar product pulled from current inventory was conducted.This testing will confirm the connectors still function as originally tested.This testing was completed and the results passed showing the connectors of currently produced atar cables meet the requirement.Review of component drawings related to female collapsing pin connector to verify nothing has changed on the design.The components of the atar cable that function the female pin receptacle connection are the collapsing pin and the pressed insert.Qa inspection data was reviewed from the female collapsing pin connector components to verify they are dimensionally stable.The dimensional inspection data was reviewed for the last five (5) lots received of each of the functional components, of the female pin receptacle connection.All lots had passing dimensional results with no failures on the aql inspected.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: ATAR D-A, DARK BLUE DISPOSABLE
• Type of Device: CABLE, ELECTRODE
• Manufacturer (Section D): OSCOR INC.; 3816 de soto blvd.; palm harbor FL 34683
• MDR Report Key: 7938460
• MDR Text Key: 123810444
• Report Number: 1035166-2018-00090
• Device Sequence Number: 1
• Product Code: IKD
• UDI-Device Identifier: 10836559006210
• UDI-Public: 10836559006210
• Combination Product (y/n): N
• PMA/PMN Number: K070926
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 10/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ATAR D-A
• Device Catalogue Number: ATAR D-A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 52