MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH 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	07/27/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the distal tip of the guidewire detached during removal from the dispenser hoop.The physician replaced it with a new guidewire and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.The subject device was returned wrapped around itself.The microcatheter used with the guidewire was not returned.Visual inspection did not reveal any damages.During functional testing, the guidewire was introduced and advanced through the a demonstration excelsior sl-10 microcatheter distal end with no resistance.The guidewire was attached to a torque device and one to one torque was checked.The guidewire torque was smooth.No other anomalies were noted.The distal tip detachment could not be confirmed.The device was confirmed to be in good condition prior to use.Therefore, an assignable cause of "not confirmed" has been assigned to the reported event.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.
Event or Problem Description
It was reported that the distal tip of the guidewire detached during removal from the dispenser hoop.The physician replaced it with a new guidewire and continued the procedure without clinical consequences to the patient.

• 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: 7793892
• Report Number: 3008880413-2018-00068
• Device Sequence Number: 13781411
• Product Code: DQX
• UDI-Device Identifier: 04546540688774
• UDI-Public: 04546540688774
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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,Followup
• Report Date (Section B): 09/20/2018

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: 03/31/2021
• Device Catalogue Number: M00326420
• Device Lot Number: 0000005990
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2018
• Initial Date Received by Manufacturer: 07/27/2018
• Supplement Date Received by Manufacturer: 09/17/2018
• Initial Report FDA Received Date: 08/17/2018
• Supplement Report FDA Received Date: 09/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1