MAUDE Adverse Event Report: OSCOR INC. BLV/BIS 4403; PACEMAKER LEAD ADAPTOR

Model Number 4403

Device Problem High impedance (1291)

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

Event Date 03/10/2022

Event Type  malfunction  

Event Description

It was reported that a rep was with a physician yesterday ((b)(6)2022) who was implanting a 4403 lead adaptor (oscor model 4403, serial no.(b)(4)) in a patient, adapting an lv (left ventricular coronary sinus) lead to a pacemaker.While implanting, the physician experienced apparently issues with tightening the setscrew of the lead adaptor, however implanted it apparently successfully.He stated, that the thresholds after the implant were great, lead impedance normal at around 500 ohms, but once in a while jumping to over 3000 ohms.The physician kept the adaptor implanted as is.

Manufacturer Narrative

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

Manufacturer Narrative

The adaptor remains in service for approximately 1 day since the 3/10/2022 event date.The investigation was focused on a review of product documentation.The device used in treatment.The device was not returned for analysis, therefore, the exact cause of the product issue cannot be determined and the clinical observation could not be confirmed.The device history records were reviewed to confirm that the device passed all applicable in-process and final inspections.However, the following controls are in place to mitigate the reported product issue.Per qa procedure (blv/bis, 4403 lead adaptor in-process & final inspection): all finished adaptors and extensions will be inspected (100%) unless otherwise specified.Resistance test : the screw seal(s) (knob on the receptacle) is slit approximately in the center.Using tweezers, verify slit of the seal is uniform.The instructions for use (ifu) informs the user: do not remove the connector of the lead to be adapted.Insert a torque wrench through both screw seals of the unipolar/bipolar lv-1 receptacle and turn the screw 1/4 - 1/2 turn (no more than 1/2 turn) counterclockwise.Insert the lead's connector completely into the receptacle part of the adaptor.Confirm that the connector pin is completely inserted.Warning: do not bend the receptacle because it might damage the lv-1 connector pin inside.Tighten both screws of the receptacle with a torque wrench.A ligature may be placed in the groove of the receptacle's end to prevent body fluids from ingressing.In addition product awareness: the adaptors are implanted in the extremely hostile environment of the human body.Because the adaptors are very small in diameter and must be very flexible, it inevitably reduces their potential performance and longevity.Adaptor 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 by damage, fracture, or by breach of their insulation.Despite all due care in design, component quality, manufacture and testing prior to sale, adaptors may be damaged by improper handling, use placement or other intervening facts.No further follow-up is required.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.

Manufacturer Narrative

H10: correction to the ifu statement instructions for use (ifu), 1.Do not remove the connector of the lead to be adapted.2.Pull out the transportation pin from the receptacle and discard it (when applicable).3.Insert a torque wrench through the screw seal of the bipolar or unipolar lv-1 receptacle and turn the screw 1/4 - ½ turn (no more than 1/2 turn) counterclockwise.4.Lubricate the connector of the lead to be adapted with sterile saline solution prior to insertion into adaptor receptacle.Insert the lead connector completely into the receptacle part of the adaptor.Confirm that the connector pin is completely inserted.5.Tighten the set-screw of the receptacle with a torque wrench.Do not overtighten the set-screw as this may cause damage to the connector of the lead being adapted.Caution: after removing the torque wrench, silicone medical adhesive may be used on the screw seal for added protection against body fluid ingression.The adapted lead will not accept a stylet! 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: BLV/BIS 4403
• Type of Device: PACEMAKER LEAD ADAPTOR
• 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: doug myers ; 3816 desoto blvd.; palm harbor, FL 34683-1816 ; 7279372511
• MDR Report Key: 13891345
• MDR Text Key: 287846055
• Report Number: 1035166-2022-00041
• Device Sequence Number: 1
• Product Code: DTD
• UDI-Device Identifier: 00836559009627
• UDI-Public: 00836559009627
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K925168
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2023
• Device Model Number: 4403
• Device Catalogue Number: 4403
• Device Lot Number: C4-14612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention