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

Model Number	M0031681910
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.Analysis of the returned device confirmed the catheter tip was bent, likely due to handling damage, and revealed that the catheter shaft was broken at approximately 143cm of the effective length of the shaft.Functional testing could not be performed due to the condition of the returned device.Information available indicated that the catheter was kinked following removal from the packaging.No damage was noted to the device packaging and the device was not used.The damage noted to the catheter is indicative of excessive force, therefore an assignable cause of handling damage was assigned.
Event or Problem Description
Analysis of the returned microcatheter (subject device) found that it was broken at approximately 131cm from the hub and at the distal tip.There was no patient involvement.

• 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: 7051381
• Report Number: 3008881809-2017-00490
• Device Sequence Number: 1629805
• Product Code: DQY
• UDI-Device Identifier: 04546540688231
• UDI-Public: (01)04546540688231(17)190531(10)19808978
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• 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): 11/21/2017

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: 05/31/2019
• Device Model Number: M0031681910
• Device Catalogue Number: M0031681910
• Device Lot Number: 19808978
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2017
• Initial Report FDA Received Date: 11/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1