MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK EXCELSIOR XT-17 FLEX STRAIGHT 150CM; CATHETER, PERCUTANEOUS

Model Number	M003C1715ST0
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the microcatheter shaft was found to be kinked and had a hole/perforation.The microcatheter tip was found to be damaged.Dimensional inspection confirmed the microcatheter dimensions were within specification.A functional test confirmed that a pin gauge met the catheter shaft when inserted into the hub and that a patency mandrel would not advance beyond the kink.The reported event is covered in the device direction for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.The reported event 'catheter kinked/bent' was confirmed during analysis.The reported 'catheter, difficulty advancing coil' could not be confirmed; however, the analysis results are consistent with the reported event.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.The product was analyzed.The catheter shaft was found to be kinked which would have caused friction trying to advance the coil.During analysis there was a hole identified near the distal tip and the distal tip was damaged.The catheter most likely became damaged due to some procedural factors during the procedure.This complaint appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use.The as reported 'catheter kinked/bent' and 'catheter, difficulty advancing coil' as well as the as analyzed 'catheter tip damaged', 'catheter shaft has hole/perforation' and 'catheter shaft kinked/bent' will be assigned procedural factors.
Event or Problem Description
The microcatheter (subject device) was returned for analysis and it was discovered that the subject device shaft had a hole/perforation.No clinical consequences were reported to the patient due to this event.

• Brand Name: EXCELSIOR XT-17 FLEX STRAIGHT 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: 15740157
• Report Number: 3008881809-2022-00552
• Device Sequence Number: 16883561
• Product Code: DQY
• UDI-Device Identifier: 07613252714903
• UDI-Public: 07613252714903
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K142565
• 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
• Report Date (Section B): 11/04/2022

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: 11/03/2023
• Device Model Number: M003C1715ST0
• Device Catalogue Number: M003C1715ST0
• Device Lot Number: 23296898
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/20/2022
• Initial Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2021
• 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: COILS (UNKNOWN).
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Weight: 52 KG
• Patient Race: Asian