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

Model Number 375535

Device Problems Improper or Incorrect Procedure or Method (2017); No Apparent Adverse Event (3189)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/06/2020

Event Type  malfunction  

Event 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.

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.

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
• Type of Device: LEAD DELIVERY SYSTEM
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 9739140
• MDR Text Key: 180810920
• Report Number: 1028232-2020-00864
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 04035479116798
• UDI-Public: 04035479116798
• Combination Product (y/n): N
• PMA/PMN Number: K110461
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 02/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 03/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1