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

Model Number BIS/BIS-40

Device Problems High impedance (1291); Over-Sensing (1438); Ambient Noise Problem (2877)

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

Event Date 04/02/2019

Event Type  Injury  

Manufacturer Narrative

Our investigation is still in progress, follow up report will be submitted if we found any further additional information.

Event Description

It was reported that, overnight adaptor was attached to the atrial lead.In morning there was impedance spike to 3000 ohms uni/bip, 625 ohms sensing, 1.5mv threshold 1.0v @ 0.4ms and noise noted.Patient was admitted for lead revision surgery, undertook provocation maneuvers and appeared to be at site of adapter.Surgical revision was performed on the left sided pocket and the adapter for atrial lead was inspected the distal setscrew was loose, doctor retightened setscrew and provocation maneuvers were done with no notable noise on the channel after fixing the setscrew.No other additional information available and no other adverse event reported.

Event Description

As per additional information there was no issue with adaptor biw07451.Adaptor remains in use.For adaptor biw07451 see medwatch 1035166-2019-00038.

Manufacturer Narrative

The device was in use for treatment and remains implanted.The device was not returned for analysis,therefore the clinical observation could not be confirmed.The investigation will focus on a review of product documentation.The device history records were reviewed to confirm that the device passed all applicable in process and final inspections.Per procedure unipolar and bifurcated bipolar lead adaptors/extensions and lead extension with universal coupler final inspection: the setscrew is checked by qa 100% both visually and with a torque wrench to ensure smooth functionality.The electrical values are checked by qa 100% as well.Electrical/mechanical inspection: check electrical continuity by using multimeter.Attach the red cable to the connector pin and black cable to the trokar needle.Insert trokar needle straight on the screw head through the seal of the connector pin receptacle on both legs and check for resistance.Insert trokar needle into the other screw for connector hull receptacle to assure that there is no electrical connection/short.Attach red cable to the connector hull and follow the same method as above for the connector hull receptacles on both legs.Set screws and transport protection pin inspection (visual inspection) screw seals (two knobs on the receptacle) are cut approximately in the center and are shaped as a trokar cut.They will open during the insertion of the screwdriver and will reseal after removing the screwdriver.Insert the appropriate "test" connector into the receptacle and tighten the set screw using the 14 in/oz torque wrench (either tn4243 or tn4244).The torque wrench must click which verifies the set screw was tightened correctly.Per instructions for use, (ifu):, bis/bis adaptor: 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.Adaptors 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 of 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.Directions for use: 1.Do not remove the connector of the lead to be adapted.2.Insert a torque wrench through the screw seals of the bipolar is-1 receptacle and turn both screws 1/4 - 1/2 turn (no more than 1/2 turn) counterclockwise and remove the white safety transportation pin "a".3.Insert the lead connector completely into the receptacle part of the extension.Confirm that the connector pin is visible in the hole "b" of the receptacle.4.Tighten both screws "c" of the receptacle with the screwdriver.A ligature may be placed in the groove of the receptacle's end to prevent body fluids from ingressing.5.After removing the screwdriver, use silicone medical adhesive on the screw seals for protection against body fluid ingression.Based on the investigation, a capa is not required as findings did not identify a design, labeling or manufacturing nonconformity.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

Corrected data: h10 : procedure is bipolar lead adaptor or/extension final inspection.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

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: LEAD ADAPTOR
• Type of Device: PACEMAKER LEAD ADAPTOR
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd; palm habror FL 34683
• MDR Report Key: 8582349
• MDR Text Key: 144141385
• Report Number: 1035166-2019-00039
• Device Sequence Number: 1
• Product Code: DTD
• UDI-Device Identifier: 00885672008369
• UDI-Public: 0885672008369
• Combination Product (y/n): N
• PMA/PMN Number: K010787
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2021
• Device Model Number: BIS/BIS-40
• Device Catalogue Number: BIS/BIS-40
• Device Lot Number: C4-13629
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention