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	04/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is not available.
Event or Problem Description
It was reported that the distal tip of the subject guidewire was broken during the procedure.The broken part was removed with the microcatheter as one unit with no clinical consequence to the patient.The procedure was completed with a new guidewire.
Additional Manufacturer Narrative
Product available to stryker - updated to 'return'.Device evaluated by mfg/summary attached - updated to 'yes'.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.Analysis of the returned device found the guidewire was separated at the proximal end.Additionally, the polytetrafluoroethylene (ptfe) coating was compressed and scrapped off at approximately 38.0cm from the proximal end.Functional testing could not be performed due to the condition of the returned device; the reported break was confirmed.Based on the results of the investigation, the guidewire break is likely due to excessive torque and manipulation during use.Therefore, aassignable cause of operational context has been assigned to the reported and analyzed "guidewire distal tip detached".The peeled ptfe coating is believed to have occurred from an insecurely torque device, per the device direction for use (dfu), "securely fasten the torque device onto the wire to prevent slippage of the torque device and to avoid product damage (i.E., core wire abrasion/peeling of ptfe, etc.)".Since the device dfu specifically cautions that insecure tightening of the torque device can lead to ptfe peeling.However, since the torque device was not returned for evaluation, an assignable cause code of 'undeterminable' has been assigned to the analyzed "guidewire ptfe coating peeling".
Event or Problem Description
It was reported that the distal tip of the subject guidewire was broken during the procedure.The broken part was removed with the microcatheter as one unit with no clinical consequence to the patient.The procedure was completed with a new guidewire.

• 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: 7484062
• Report Number: 3008880413-2018-00035
• Device Sequence Number: 19218147
• Product Code: DQX
• UDI-Device Identifier: 04546540688774
• UDI-Public: (01)04546540688774(17)201130(10)0000002232
• 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,Followup
• Report Date (Section B): 07/03/2018

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: 11/30/2020
• Device Model Number: M00326420
• Device Catalogue Number: M00326420
• Device Lot Number: 0000002232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2018
• Initial Date Received by Manufacturer: 04/09/2018
• Supplement Date Received by Manufacturer: 06/22/2018
• Initial Report FDA Received Date: 05/03/2018
• Supplement Report FDA Received Date: 07/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR