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

Model Number	M00326420
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/29/2016
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 subject guidewire was returned along with the microcatheter used in the procedure.Analysis of the returned device revealed that the guidewire nitinol was separated at approximately 3.2 cm from its nitinol distal end.The platinum coil was slightly stretched.The guidewire was bent at 142.0cm from its proximal end.Bubbles were found on the guidewire distal 15.0cm hydrophilic section.During functional evaluation, the guidewire was loaded and advanced through the proximal end of returned microcatheter.The guidewire came out of the microcatheter distal end, with slight friction experienced during advancement.The guidewire was attached to a torque device and one to one torque was checked.The guidewire torque was not smooth.Information available confirmed that the device was in a good condition prior to use.Based on the information currently available and device analyses, the cause of the analyzed guidewire distal tip detachment could not be determined.
Event or Problem Description
Analysis of the returned device revealed that the guidewire distal tip was detached.There were no reported patient complications associated with this event.

• Brand Name: SYNCHRO 2/14 200 CM STANDARD PRESHAPED
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): STRYKER NEUROVASCULAR-UTAH; 2405 orion circle; west valley city UT 84119
• MDR Report Key: 6874105
• Report Number: 3008880413-2017-00039
• Device Sequence Number: 705794
• Product Code: DQX
• UDI-Device Identifier: 04546540688774
• UDI-Public: (01)04546540688774(17)190930(10)B43275
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 09/18/2017

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: 09/30/2019
• Device Model Number: M00326420
• Device Catalogue Number: M00326420
• Device Lot Number: B43275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2017
• Initial Report FDA Received Date: 09/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1