MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO 2/14 200 CM STANDARD PRESHAPED; WIRE, GUIDE, CATHETER

Catalog Number	M00326420
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/08/2018
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.During the analysis of the returned device, it was revealed that the guidewire was kinked, and the distal tip was separated.In addition, there was foreign matter and the device was contaminated with lint.During the functioning test, it was found that slight friction was noticed during the advancement; however, it could not be confirmed.Additional information provided by the customer indicated that the guidewire was in good condition prior to use and prepared as per the dfu (direction for use), the microcatheter was flushed to facilitate guidewire insertion and the introducer was used during the insertion process.It is probable that difficulty in inserting the guidewire into the microcatheter and handling of the guidewire during the preparation may have caused the anomalies (guidewire bent and separated) and lint and foreign substance observed during the visual inspection.Therefore, a cause of handling damage was assigned to the analyzed defects of the guidewire.
Event or Problem Description
During the analysis of the returned device, it was reported that the guidewire distal tip was separated.No clinical consequences reported to the patient.

• Brand Name: SYNCHRO 2/14 200 CM STANDARD PRESHAPED
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT
• MDR Report Key: 7824385
• Report Number: 3012931345-2018-00002
• Device Sequence Number: 1720015
• Product Code: DQX
• UDI-Device Identifier: 04546540688774
• UDI-Public: 04546540688774
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K053268
• 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): 08/28/2018

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: 02/10/2020
• Device Catalogue Number: M00326420
• Device Lot Number: 0000005894
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2018
• Initial Report FDA Received Date: 08/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR