MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK EXCELSIOR XT 27 MICROCATHETER PS 150; CATHETER, PERCUTANEOUS

Catalog Number	M003XT2750910
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The electronic device history record (edhr) review confirms that the device met all material, assembly and performance specifications.During visual inspection, the catheter shaft was noted to be stretched and broken near the distal end.During functional testing, the catheter was flushed, and a patency mandrel was advanced through the catheter shaft without difficulty until the damage section of the catheter shaft was reached, where friction was noted.In case of this complaint, no anomalies were noted to the device prior to use.The damage noted to the distal shaft of the catheter is indicative of excessive fore though this cannot be conclusively determined.The catheter is likely to have been damage during use resulting in the reported events.An assignable cause of procedural factor was assigned to the as analyzed issue catheter shaft broken/fractured, as the issue is associated with a product that meets stryker design and manufacture specification and was used according to the direction for use (dfu) but due to procedural and/or anatomical factors during use, the device performance was limited.
Event or Problem Description
During device investigation, the catheter shaft was found broken.No consequences to the patient was reported.

• Brand Name: EXCELSIOR XT 27 MICROCATHETER PS 150
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8491889
• Report Number: 3008881809-2019-00091
• Device Sequence Number: 11208432
• Product Code: DQY
• UDI-Device Identifier: 04546540698155
• UDI-Public: 04546540698155
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• 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
• Report Date (Section B): 04/08/2019

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: 06/12/2021
• Device Catalogue Number: M003XT2750910
• Device Lot Number: 20618355
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2019
• Initial Report FDA Received Date: 04/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NEUROFORM3 EZ STENT (STRYKER)
• Patient Age: 76 YR