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

Model Number 4403

Device Problem High impedance (1291)

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

Event Date 10/01/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported the lv (left ventricular) lead has a history of out of range (oor) impedances.At this time the event is associated with the lv lead, adaptor and device.At this time root cause is unknown, the oor impedances seen on daily measurements taken by device.Pending root cause and resolution regarding high oor lv lead impedances.No adverse patient effects reported.The adaptor remains implanted.

Manufacturer Narrative

The adaptor is in use for treatment and remains implanted for approximately 8 years, therefore, the clinical observation cannot be confirmed.The adaptor passed all in-process and qa final inspection before shipping to the customer.Per qa procedure: all finished adaptors and extensions will be inspected (100%) unless otherwise specified.11.2.2 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.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.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
• MDR Report Key: 8704472
• MDR Text Key: 148283283
• Report Number: 1035166-2019-00052
• Device Sequence Number: 1
• Product Code: DTD
• UDI-Device Identifier: 00836559009627
• UDI-Public: 00836559009627
• 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: 08/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2013
• Device Model Number: 4403
• Device Catalogue Number: 4403
• Device Lot Number: C2-11508
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR