MAUDE Adverse Event Report: OSCOR INC. UNIPOLAR 6MM LEAD ADAPTER; PACEMAKER LEAD ADAPTOR

Model Number	C/IS-10 SS2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The adaptor was explanted due to an infection.It will not be returned for analysis as it was disposed of, therefore a root cause could not be determined.The investigation will focus on the potential for this failure mode and a review of product documentation.Oscor's sterility and lal tests show that the product levels are within specifications.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 records and the complaint files of the device model were reviewed.The event will be re-evaluated if additional information becomes available.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 inspection 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.Instructions for use, lead adaptors are indicated for connecting the existing pacing lead(s) to a compatible pacemaker header cavity.Lead extensions are indicated for extending 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.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.Do not get medical adhesive in the connector pins.The adapted/extended lead will not accept a stylet.Product awareness 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.
Event or Problem Description
This adapter was explanted (b)(6) 2017 due to infection.

• Brand Name: UNIPOLAR 6MM LEAD ADAPTER
• Common Device Name: PACEMAKER LEAD ADAPTOR
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683 1816
• MDR Report Key: 6964520
• Report Number: 1035166-2017-00090
• Device Sequence Number: 1142572
• Product Code: DTD
• UDI-Device Identifier: 00885672102739
• UDI-Public: 00885672102739
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K925168
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Expiration Date: 08/01/2019
• Device Model Number: C/IS-10 SS2
• Device Catalogue Number: C/IS-10 SS2
• Device Lot Number: C1-12691
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2017
• Initial Report FDA Received Date: 10/20/2017
• 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
• Patient Age: 51 YR