MAUDE Adverse Event Report: OSCOR INC. MEDTRONIC REUSABLE EXTENSION CABLE; CABLE, ELECTRODE

Model Number 53912

Device Problem Break (1069)

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

Event Date 12/27/2016

Event Type  malfunction  

Manufacturer Narrative

The customer reported there were four (4) complaints related to this extension cable; all were from the same end user, with no patient involvement.The customer reported additional information that only three (3) cables would be returned for analyses, and that the cables were not reused or resterilized.A review of the device history records could not be performed as the lot number of these cables are unknown.Per analysis, three (3) extension cables were returned from the customer.There were no other accessories, and no visible blood was found anywhere on the extension cables.Cable (b)(4): the cable was returned without the negative connector or strain relief present with the rest of the device.The plug connector has adhesive residue on the outer surface.The wires of the negative connector are twisted at the location of the break.The negative connector and strain relief are missing from the device.Without the connector, the location of the break cannot be confirmed.The cause of the detachment is most likely cause by a torsional stress applied to the wires soldered to the negative connector.The dimensional and functional observations that could be obtained are within manufacturing specifications.Cable (b)(4): the cable was returned with the negative connector and strain relief separated from the rest of cable.The negative connector broke at the exposed wires adjacent to the solder joint.The negative connector and strain relief were separated from the rest of the cable.The failure occurred on the negative connector at the exposed portion of wires adjacent to the solder joint.The dimensional and functional observations that could be obtained are within manufacturing specifications.Cable (b)(4): the cable was returned with the negative connector and strain relief separated from the rest of cable.A "catheter lab" tag was attached to the strain relief of the positive connector.The negative connector broke at the exposed wires adjacent to the solder joint.The negative connector and strain relief were separated from the rest of the cable.The failure occurred on the negative connector at the exposed portion of wires adjacent to the solder joint.The dimensional and functional observations that could be obtained are within manufacturing specifications.Based on this investigation a capa has been opened to address this failure.Oscor will continue to monitor this device for complaint trends and risk.Per cable inspection procedure during in process inspection, the cable is inspected 100% for continuity.During final inspection, each strand of the cable is checked for the correct colored part, overall length of the cable, cable checked for damage and insulation voids, verification that the silicone strain relief extends at least for a length of 2 cm outside the female connector, checked that the silicone strain relief fits the wire snugly, checks for strain relieves for damage and gaps, a pull test is done on each connector and pin, and the cable is inspected again for continuity.The instructions for use (ifu) informs the user: for reusable cables only: the cables can be re-sterilized by oscor eto gas sterilization a maximum of two times.The directions for use inform the user to: 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.Precautions include: 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.

Event Description

It was reported that four connectors broke under normal use.The connectors are expected to be returned.There was no patient involvement.Additional information was received that only three cables would be returned analyses, and the cables were not reused or resterilized.

• Brand Name: MEDTRONIC REUSABLE EXTENSION CABLE
• Type of Device: CABLE, ELECTRODE
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683 1816
• Manufacturer (Section G): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683 1816
• Manufacturer Contact: dorit segal ; 3816 desoto blvd.; palm harbor, FL 34683-1816 ; 7279372511
• MDR Report Key: 6605577
• MDR Text Key: 76527670
• Report Number: 1035166-2017-00042
• Device Sequence Number: 1
• Product Code: IKD
• UDI-Device Identifier: 00885672101930
• UDI-Public: 00885672101930
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070926
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 53912
• Device Catalogue Number: 53912
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1