MAUDE Adverse Event Report: OSCOR INC. BIPOLAR IS-1 LEAD ADAPTOR; PACEMAKER LEAD ADAPTOR

Model Number	B/IS-15 SS2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/05/2018
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.The adaptor was actively implanted for approximately 5 years, 7 months.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 one additional complaint.Based on the investigation, a capa is not required as findings did not identify a design, labeling or manufacturing non-conformity or new failure mode.Oscor will continue to monitor this event type.Per qa unipolar and bipolar lead adaptors/extensions with self-sealing feature procedure, all products must meet pre-determined specifications in each step of the inspection procedure including crimp, laser weld, inner coil to connector pin and inner pu tubing positioning, physical / mechanical inspection includes length measurements, insertion/ withdrawal force test on is-1 connector, pull test when applicable, dimensional and connector measurements.Applicable electrical.Cosmetic and documentation reviews are completed.Per qa labeling /packaging criteria and inspection prior to sterilization, check that a steri-dot is present and properly located in tray or pouch.Per qa procedure final labeling/packaging inspection of all products, 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.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 the device and adaptor were explanted, and the leads were abandoned.

• Brand Name: BIPOLAR IS-1 LEAD ADAPTOR
• Common Device Name: PACEMAKER LEAD ADAPTOR
• Manufacturer (Section D): OSCOR INC.; 3816 de soto blvd.; palm harbor FL 34683
• MDR Report Key: 7732502
• Report Number: 1035166-2018-00069
• Device Sequence Number: 1405668
• Product Code: DTD
• UDI-Device Identifier: 00885672102722
• UDI-Public: 00885672102722
• 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: 2012
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/30/2018

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: 09/01/2013
• Device Model Number: B/IS-15 SS2
• Device Catalogue Number: B/IS-15 SS2
• Device Lot Number: C1-05861
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/04/2018
• Initial Report FDA Received Date: 07/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 0041/107070; 0041/107078; 4312/022197; 4312/022226; E141/101162
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention