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

Catalog Number	M0031681930
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record confirms that the device met all material, assembly and performance specifications.Visual and microscopic examination of the returned device found that the catheter was kinked and broken.During functional testing, a pin guage was verified to meet the catheter shaft when inserted into the catheter hub.The patency mandrel was not advanced through the catheter due to the damage noted to the device.Based on the investigation findings, it is possible that the catheter was broken fractured which may have been reported as a kink/bent.The catheter tip was also seem to be kinked bent.Based on the investigation results and available information, an assignable cause of procedural factors will be assigned to the investigation.
Event or Problem Description
Based on the investigation of the returned product, the catheter shaft was broken.There were no clinical consequences to the patient.

• Brand Name: EXCELSIOR SL-10 PRE-SHAPED C 150CM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8646155
• Report Number: 3008881809-2019-00146
• Device Sequence Number: 16740910
• Product Code: DQY
• UDI-Device Identifier: 04546540688255
• UDI-Public: 04546540688255
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/28/2019

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: 07/30/2020
• Device Catalogue Number: M0031681930
• Device Lot Number: 20763782
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2019
• Initial Report FDA Received Date: 05/28/2019
• 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: SYNCHRO GUIDEWIRE (STRYKER)