Model Number 375535 |
Device Problems
Improper or Incorrect Procedure or Method (2017); No Apparent Adverse Event (3189)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/06/2020 |
Event Type
malfunction
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Event Description
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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.
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Manufacturer Narrative
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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.
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Manufacturer Narrative
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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.
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Search Alerts/Recalls
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