MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK EXCELSIOR SL-10 PRE-SHAPED 90 150CM; CATHETER, PERCUTANEOUS

Catalog Number	M0031681910
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.The microcatheter was returned with the stryker stent used during the procedure.Visual inspection revealed that the stent delivery wire (sdw) was protruding from the microcatheter hub, the catheter shaft was damaged and the distal tip of the catheter was also noted to be broken/fractured.No other anomalies were observed.Functional testing could not be performed due to the damaged condition of the returned device.Information available indicated that the patient's anatomy was a little tortuous.It is likely that procedural factors contributed to the reported and observed damages limiting the performance of the microcatheter during the clinical procedure.Therefore, an assignable cause of component failure has been assigned to this investigation.
Event or Problem Description
Analysis of the returned device noted that the microcatheter tip was broken.No consequences to the patient were reported.

• Brand Name: EXCELSIOR SL-10 PRE-SHAPED 90 150CM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8333603
• Report Number: 3008881809-2019-00043
• Device Sequence Number: 986290
• Product Code: DQY
• UDI-Device Identifier: 04546540688231
• UDI-Public: 04546540688231
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• PMA/510(K) Number: K042568
• 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): 02/12/2019

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: 06/25/2020
• Device Catalogue Number: M0031681910
• Device Lot Number: 20685754
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2019
• Initial Report FDA Received Date: 02/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1