MAUDE Adverse Event Report: OSCOR INC UNIPOLAR 6MM LEAD ADAPTOR; PACEMAKER LEAD ADAPTOR

Catalog Number C/IS-10 SS2

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 05/01/2017

Event Type  Injury  

Manufacturer Narrative

Conclusion not yet available-evaluation in progress.

Event Description

The brady adapter was explanted due to an unknown product performance issue.

Manufacturer Narrative

The following sections were updated in follow-up #1: date of report, concomitant medical products, date rec¿d by mfr, if follow-up, what type, device evaluated by mfr, device manufacture date, and labeled for single use.According to the reported incident, there was a product performance issue, unspecified.Despite attempts at obtaining clarification, no additional information was provided by the reporter.There were no manufacturing rejects or anomalies of this event type recorded in the device history record.A complaint review of the reported manufacturing lot found no additional similar reports.The lead adaptor passed all in-process and qa final inspection before shipping to the customer, including mechanical, dimensional, electrical and visual testing.Per procedure, unipolar and bifurcated bipolar lead adaptors/extensions and lead extension with universal coupler final inspection, it states: all products must meet pre-determined specifications in each step of the inspection procedure including crimp, laser weld, inner coil to connector pin and inner pu tubing positioning, physical / mechanical inspection includes length measurements, insertion/ withdrawal force test on is-1 connector, pull test when applicable, dimensional and connector measurements.Applicable electrical, cosmetic and documentation reviews are completed.Per instructions for use (ifu) it lists possible complications that include: as with the introduction of any foreign object into the body, an infection might result.Removal of the device may be required.Intermittent or continuous loss of pacing and sensing may be caused by the device's poor connection, disconnection, or damage.One adaptor was received back from the customer.There were no other accessories.Blood was found on and inside the receptacle of the adaptor.The connector pin, welds and silicone o-rings looked normal.Upon evaluation of the returned adaptor, it was found that the setscrew was intact and in the correct position inside the hole in the adaptor and functioned properly when tested with a torque wrench.The electrical measurements were tested with a multimeter and the values were within manufacturing specifications.Returned device analysis reveals an adaptor within manufacturing specifications.According to the incident report, there was a product performance issue.It is unclear given the lack of details what the actual product performance issue was.No manufacturing defects were found.Investigation findings determined there was no complaint against the device.The reason for return cannot be confirmed.Based on the investigation, a capa is not required as findings did not identify a design, labeling or manufacturing non-conformity.The event will be re-evaluated if additional information becomes available.Oscor will continue to monitor this event type and risk.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: UNIPOLAR 6MM LEAD ADAPTOR
• Type of Device: PACEMAKER LEAD ADAPTOR
• Manufacturer (Section D): OSCOR INC; 3816 desoto blvd; palm harbor FL 34683 1816
• MDR Report Key: 6635004
• MDR Text Key: 77393731
• Report Number: 1035166-2017-00047
• Device Sequence Number: 1
• Product Code: DTD
• UDI-Device Identifier: 00885672102739
• UDI-Public: 00885672102739
• Combination Product (y/n): N
• PMA/PMN Number: K925168
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 04/01/2019
• Device Catalogue Number: C/IS-10 SS2
• Device Lot Number: C1-12421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/13/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention