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

Model Number 59312

Device Problem Pacing Problem (1439)

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

Event Date 02/09/2015

Event Type  malfunction  

Manufacturer Narrative

This report is part of an internal retrospective review of complaints, conducted by oscor as a result of process improvements made to the complaint system to ensure proper medical device reporting is maintained.As part of the detailed review, this event has been determined to be reportable.This initial mdr is being submitted to meet our requirements of reporting.Product analysis report was processed on (b)(4).A kink was observed on the positive cable.This could have been caused by either the handling of the device by the customer or doctor.There was also a black scuff mark on the strain relief of the positive cable.The scuff mark appears in line with the end of the electrode pin.This could have been caused by some sort of impact with another object such as the ground or from the use of a tool to remove the pin.After the strain relief was carefully removed from the positive electrode pin, it was found that the wires in the cable were no longer attached to the pin, which explains the failure to pace.Also, the end of the pin where the wires are connected was out of round compared to the negative electrode pin.This was due to two dents on either side of the pin.This looks like it could have been caused by teeth on a pair of pliers.If there was problem with the pin after final assembly, the part would have been rejected because these parts are inspected 100 percent for continuity and function of the pin.Per the cable inspection procedure 4b-51-006z-e, 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 returned device analysis reveals that the atar mdts extension cable is within manufacturing specifications.No manufacturing defects were found.The reason for return cannot be confirmed.The instructions for use (ifu) ma-17-005z-x 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

During a trans-catheter aortic valve replacement (tavr) case the external pulse generator (epg) failed to rapid atrial pace.When epg connected to new cable appropriate pacing occurred.

• 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
• MDR Report Key: 6494321
• MDR Text Key: 72882298
• Report Number: 1035166-2017-00030
• 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: 04/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 59312
• Device Catalogue Number: 59312
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/09/2015
• 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