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

Model Number	BIS/IS-15
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The adaptor was used in treatment.It was explanted due to an infection and it was not returned for analysis, therefore a root cause could not be determined.The investigation will focus on review of product documentation.No allegation our device failed to meet its performance specifications or caused or contributed to the infection.Proof of sterilization is on file.Infection is a recognized clinical event referenced in the device's labeling and/or reported in the medical literature.The device history record was reviewed to confirm that the device passed all applicable in-process and final inspections.A review of complaints against this sterilization lot number identified no additional complaints.Based on the investigation, a capa is not required as findings did not identify a design, labeling or manufacturing nonconformity or new failure mode.Oscor will continue to monitor this event type.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 bipolar pacing lead adaptors self-sealing instructions for use (ifu) informs the user lead adaptors are indicated for connecting the existing pacing lead(s) to a compatible pacemaker header cavity.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.No adverse effects known.Possible complications: infection.As with the introduction of any foreign object into the body, an infection might result.
Event or Problem Description
The customer reported "complete system extracted due to infection.".Device/lead sns (b)(4) were removed on (b)(6) 2018.
Additional Manufacturer Narrative
The following sections were updated in follow-up.
Event or Problem Description
As per additional information no adverse events, effects were reported.

• Brand Name: LEAD ADAPTOR
• Common Device Name: PACEMAKER LEAD ADAPTOR
• Manufacturer (Section D): OSCOR INC.; 3816 de soto blvd.; palm harbor FL 34683
• MDR Report Key: 7786723
• Report Number: 1035166-2018-00073
• Device Sequence Number: 16622093
• Product Code: DTD
• UDI-Device Identifier: 00836559002680
• UDI-Public: 00836559002680
• 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: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2018

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: 10/01/2019
• Device Model Number: BIS/IS-15
• Device Catalogue Number: BIS/IS-15
• Device Lot Number: C4-13107
• Initial Date Received by Manufacturer: 07/23/2018
• Supplement Date Received by Manufacturer: 08/21/2018
• Initial Report FDA Received Date: 08/15/2018
• Supplement Report FDA Received Date: 10/18/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 81 YR