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

Model Number	BLV/BIS-4403
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Known Impact Or Consequence To Patient (2692)
Date of Event	10/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Conclusion not yet available, evaluation in process.A follow-up will be submitted as soon as the investigation is complete.
Event or Problem Description
It was reported per call from the field representative, that system was infected and entire system was removed (laser extracted) today.Unclear if patient on iv antibiotics.Device will be returned.Leads were used for cultures.Very clearly infected.Additional information requested.
Additional Manufacturer Narrative
The following sections were updated in follow-up 1: b4, g4, g7, h2, h6 and h10: the adaptor was in use for treatment.The adaptor was not returned for analysis, location of adaptor was not available.There was no specific performance related failure reported by the user.The adaptor was in service for 20 days before being explanted on 10/22/2019.The device history records were reviewed to confirm the device passed all applicable in-process and final inspections.Per qa procedure final labeling/packaging inspection of all products: all labeling and packaging will be inspected 100%.Check for foreign material and tyvek seal integrity.Verify that color of steri-dot changed from brown to green, where applicable.Sealed areas (tyvek lid to lip of tray and pouch) are continuous around entire perimeter of tray.No voids, breaks, and or bubbles along the seal.The entire seal should be at least ¼ inch wide and have a full ridge.The tyvek pull tab must be properly folded into position.Examine the seal and border for uniformity of the seal.Check for holes or any other damages that could violate sterility.The instructions for use (ifu) blv/bis in forms the user: cautions - device is supplied sterile.Do not use if package has been previously opened or damaged.Prior to use, read all package inserts, warnings, precautions, and instructions.Failure to do so may result in severe patient injury or death.Procedure must be performed by trained medical personnel well versed in anatomical landmarks, safe technique, and potential complications.The device is designed for single use only.Do not resterilize or reuse.Do not alter the device in any way.Possible complications - infection.As with the introduction of any foreign object into the body, an infection might result.Removal of the device may be required.Intermittent or continuous loss of pacing and sensing may be caused by the device's poor connection, or disconnection, or damage.No allegation our device failed to meet its performance specifications or caused or contributed to the infection.Infection is a recognized clinical event referenced in the device's labeling and/or reported in the medical literature.Based on the investigation, a capa is not required.The event will be re-evaluated if additional information becomes available.No further follow-up is required.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
• Common Device Name: PACEMAKER LEAD ADAPTOR
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683
• MDR Report Key: 9540867
• Report Number: 1035166-2020-00001
• Device Sequence Number: 2641803
• Product Code: DTD
• UDI-Device Identifier: 00836559009627
• UDI-Public: 00836559009627
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K925168
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/01/2020
• Device Model Number: BLV/BIS-4403
• Device Catalogue Number: BLV/BIS-4403
• Device Lot Number: C4-13345
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/17/2019
• Supplement Date Received by Manufacturer: 03/26/2020
• Initial Report FDA Received Date: 01/02/2020
• Supplement Report FDA Received Date: 03/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention