MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG SELECTRA RIGHT-45; LEAD DELIVERY SYSTEM

Model Number	375535
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/06/2020
Type of Reportable Event	Malfunction
Event or Problem Description
We received notification from a hospital on (b)(6) 2020 that an expired catheter was used during an implant procedure.The procedure occurred on (b)(6) 2020, but the ubd of the catheter was (b)(6) 2019.No adverse patient side effects have been reported.No part of the catheter remains in the patient.The catheter was discarded by the hospital after use.Should additional information be received, this file will be updated.
Additional Manufacturer Narrative
As of today, the medical device is not available for analysis, therefore the device itself could not be investigated.The analysis is thus based on the inspection of the manufacturing documents of the device.The manufacturing process for this device was re-investigated.All production steps had been performed accordingly.There was no sign of any inconsistency during the manufacturing process.There is no data available to biotronik demonstrating the sterility of selectra catheters beyond ubd.Should additional information or the device itself become available for analysis, the investigation will be updated.
Additional Manufacturer Narrative
The analysis conclusion codes have been updated by the manufacturer.As of today, the medical device is not available for analysis, therefore the device itself could not be investigated.The analysis is thus based on the inspection of the manufacturing documents of the device.The manufacturing process for this device was re-investigated.All production steps had been performed accordingly.There was no sign of any inconsistency during the manufacturing process.There is no data available to biotronik demonstrating the sterility of selectra catheters beyond ubd.Should additional information or the device itself become available for analysis, the investigation will be updated.

• Brand Name: SELECTRA RIGHT-45
• Common Device Name: LEAD DELIVERY SYSTEM
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 9739140
• Report Number: 1028232-2020-00864
• Device Sequence Number: 2401221
• Product Code: DQY
• UDI-Device Identifier: 04035479116798
• UDI-Public: 04035479116798
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K110461
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/17/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: 375535
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 10172492
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/17/2020
• Supplement Date Received by Manufacturer: 03/03/2020; 03/30/2020
• Initial Report FDA Received Date: 02/21/2020
• Supplement Report FDA Received Date: 03/04/2020; 04/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1