MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK EXCELSIOR XT-27 FLEX PRE-SHAPED 150CM; CATHETER, PERCUTANEOUS

Model Number	M003XT2750920
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
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.
Additional Manufacturer Narrative
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'.
Event or Problem Description
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.

• Brand Name: EXCELSIOR XT-27 FLEX PRE-SHAPED 150CM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 13006377
• Report Number: 3008881809-2021-00532
• Device Sequence Number: 17374909
• Product Code: DQY
• UDI-Device Identifier: 04546540698162
• UDI-Public: 04546540698162
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K113778
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2022

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: 01/03/2024
• Device Model Number: M003XT2750920
• Device Catalogue Number: M003XT2750920
• Device Lot Number: 22669821
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2021
• Supplement Date Received by Manufacturer: 03/13/2022
• Initial Report FDA Received Date: 12/14/2021
• Supplement Report FDA Received Date: 03/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DERIVO FLOW DIVERTER (ACANDIS).
• Patient Sex: Female