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

Model Number C/IS-10

Device Problem Ambient Noise Problem (2877)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/22/2021

Event Type  malfunction  

Manufacturer Narrative

Conclusion not yet available, evaluation in process.A follow-up report will be submitted as soon as the investigation is complete.

Event Description

It was reported patient had generator changed-out on (b)(6) 2021 that required two 6mm lead adaptors.Noise was observed with isometric exercise testing right ventricular (univ2711) and right atrial (unknown).Device detection of noise appropriate and responding correctly, adaptors remain implanted; physician is monitoring patient.No adverse patient effects were reported.Reference 1035166-2021-00043 for unknown serial number.

Manufacturer Narrative

The adaptor is use for treatment and remains implanted, therefore, the clinical observation cannot be confirmed.However, the following controls are in place to mitigate the reported adaptor issue.The device history records were reviewed to confirm that the adaptor passed all applicable in-process and final inspections.Per procedure unipolar and bifurcated bipolar adaptors/extensions final inspection: sampling size, all finished adaptors/extensions will be inspected 100% unless otherwise specified.Acceptance criteria - all products must meet pre-determined specifications in each step of this procedure.If product does not comply with specifications, it must be rejected.For product that does not meet predefined electrical specifications (resistance, electrical inspection, hipot) it must be reviewed with engineering for risk evaluation and escalation.This is to be conducted according to the material review process and non-conformance processing procedure.Also, an unusual or questionable or often repeating defect must be reported to qa management immediately.Electrical inspection - record the inspection results on record of measurements and rejected materials for unipolar lead adaptors/extensions.Per instructions for use (ifu) unipolar adaptors/extensions: device is supplied sterile.Do not use if package has been previously opened or damaged.Procedure must be performed by trained medical personnel well versed in anatomical landmarks, safe technique, and potential complications.Insert the connector pin of the lead into the receptacle portion of the adaptor/extension until the connector pin is completely inserted into the metal portion of the sleeve of the receptacle.Using a screwdriver, tighten the screw by turning it clockwise until resistance is met.Pull gently on the adaptor/extension to confirm that the connection is secure.Check the adapted/extended lead for electrical continuity by rechecking the threshold values.Secure the silicone sleeve of the adaptor by using a non-absorbable suture tie in the groove provided, at the distal end of the adaptor/extension.Fill the screw hole with silicone medical adhesive (not included in this package).The adaptors/extensions are implanted in the extremely hostile environment of the human body.Because the adaptors/extensions are very small in diameter and must be very flexible, it inevitably reduces their potential performance and longevity.Adaptors/extensions may fail to function for a variety of causes, including medical complications, body rejection phenomenon, allergic reaction, fibrotic tissue problem, or a failure of adaptor/extension by damage, fracture, or by breach of their insulation.Despite of all due care in design, component quality, manufacture and testing prior to sale, adaptors/extensions may be damaged by improper handling, use, placement or other intervening facts.Based on the investigation, a capa is not required as findings did not identify a design, labeling or manufacturing non-conformity.In addition, there was no new failure mode identified and the risk remains acceptable.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: OSCOR UNIPOLAR LEAD ADAPTOR
• Type of Device: PACEMAKER LEAD ADAPTOR
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683
• MDR Report Key: 11801035
• MDR Text Key: 250830048
• Report Number: 1035166-2021-00042
• Device Sequence Number: 1
• Product Code: DTD
• UDI-Device Identifier: 00836559002611
• UDI-Public: 00836559002611
• 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
• Type of Report: Initial,Followup
• Report Date: 09/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2022
• Device Model Number: C/IS-10
• Device Catalogue Number: C/IS-10
• Device Lot Number: C4-14465
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 74 YR