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

Model Number BIS/BIS-40

Device Problems High impedance (1291); Noise, Audible (3273)

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

Event Date 06/05/2023

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.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.

Event Description

The customer reported once extender connected, atrial signal noisy, impedance >3000 ohms.Device not implanted.

Manufacturer Narrative

One bis/bis-40 adaptor was returned from the customer.There were no other accessories.Slight traces of blood were found on and inside the product.According to the event description summary, after the adaptor was connected to the existing lead, and then connected to the ipg, the lead exhibited high impedance and noise.The physician proceeded to test the original lead after disconnecting the extender and it was within normal limits.The adaptor was tested with a multimeter and all of the electrical values were within manufacturing specifications.It is possible that the physician didn't make a secure connection with the lead or there could have been debris somewhere between the connection points.Patient anatomy can also be a contributing factor.Per qa procedure (bipolar lead adaptors/extensions final inspection).Sample size: 100% check electrical resistance by using a multimeter and record the measurements on the device history record.Per ifu; 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.Insert the lead connector completely into the receptacle part of the extension.Confirm that the connector pin is visible in the hole of the receptacle.Tighten both screws of the receptacle with the screwdriver.Returned device analysis revealed the adaptor was within manufacturing specifications.The electrical values were within manufacturing specifications when tested with a multimeter.An adaptor itself cannot cause a lead to exhibit high impedance and noise and also cannot function by itself.High impedance and noise would be created by lead placement, patient anatomy, etc.It is possible that the adaptor wasn't securely connected to the header of the pacemaker, or the lead wasn't securely connected inside the receptacle of the adaptor.According to the device history record and current analysis, the adaptor passed all in-process and qa final inspection steps.No manufacturing defects were found.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: BIS/BIS LEAD ADAPTOR
• Type of Device: PACEMAKER LEAD ADAPTOR
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683
• Manufacturer (Section G): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683
• Manufacturer Contact: daniel naut ; 3816 desoto blvd.; palm harbor, FL 34683 ; 7279372511
• MDR Report Key: 17362335
• MDR Text Key: 319443362
• Report Number: 1035166-2023-00071
• Device Sequence Number: 1
• Product Code: DTD
• UDI-Device Identifier: 00836559003151
• UDI-Public: 00836559003151
• 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
• Report Date: 08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2023
• Device Model Number: BIS/BIS-40
• Device Catalogue Number: BIS/BIS-40
• Device Lot Number: C4-14863
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2023
• Date Manufacturer Received: 08/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2020
• 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): Other
• Patient Sex: Male