Model Number M003XT2750920 |
Device Problem
Material Puncture/Hole (1504)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/15/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The device is not available to the manufacturer.
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Event Description
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It was reported that during the treatment of a cerebral aneurysm procedure, while advancing the flow diverter inside the subject microcatheter the physician found a hole/ perforation in the transition between the hydrophilic and proximal parts of the subject microcatheter.The flow diverter was coming out of the perforation in the subject microcatheter instead of the distal lumen.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
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Manufacturer Narrative
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H3 device evaluated by mfg updated.H3 summary attached updated.H4 manufacturing date added.D4 expiration date added.D10 product available to stryker updated.D10 returned to manufacturer on updated.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.During the visual inspection, the catheter was found to be kinked/bent.The catheter shaft was found to be hole/perforation and flattened/crushed.During functional test, the subject catheter was flushed and the leakage from the hole/perforation was noted.The reported event is covered in the device directions for use (dfu).No additional information was provided by the customer.The damage noted to the device would be indicative of the as reported defect.It was seen that the catheter shaft was kinked, crushed and had a hole.The catheter most likely was damaged during the procedure due to some procedural/anatomical factors encountered during use leading to the as reported and as analyzed defects.Based on the investigation results and available information, an assignable cause of procedural factors will be assigned to the as- reported and as analyzed 'catheter shaft has hole/perforation' as well as the as analyzed 'catheter shaft kinked/bent' and 'catheter shaft flat/crushed'.
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Event Description
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It was reported that during the treatment of a cerebral aneurysm procedure, while advancing the flow diverter inside the subject microcatheter the physician found a hole/perforation in the transition between the hydrophilic and proximal parts of the subject microcatheter.The flow diverter was coming out of the perforation in the subject microcatheter instead of the distal lumen.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
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Search Alerts/Recalls
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