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 Known Impact Or Consequence To Patient (2692)
Date of Event	08/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device is not available.
Event or Problem Description
It was reported that the guidewire was broken off during manipulation of the wire.A snare was used to remove the broken wire from the patient's body and a new guidewire was used to complete the procedure.There was no clinical consequence to the patient due to the reported event.
Additional Manufacturer Narrative
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 found to be in two fragments.The proximal fragment was approximately 191.0cm long the guidewire distal section was approximately 9.0cm long.The guidewire distal nitinol and core wire were separated, and the platinum coil sections were protruding through the nitinol at the separated sections.Additionally, the platinum coil was severely stretched and separated.No anomalies were noted with the guidewire ptfe (polytetrafluoroethylene) coating or the wet hydrophilic coating.Functional testing could not be performed as the guidewire was returned in two fragments.Additional information provided by the customer indicated that the device was confirmed to be in good condition after unpacking and preparation, continuous flush was maintained, the guidewire was prepared per the device direction for use (dfu), torque device was used on the guidewire and the patient's anatomy was moderately tortuous.Although the information from the customer indicate that no resistance was encountered during the manipulation of the guidewire, it is possible that the patient's moderately tortuous anatomy may have potentially required excessive torqueing and manipulation during the procedure resulting in the breakage of the guidewire distal tip.The reported issue is associated with the device that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.Therefore, an assignable cause of operational problem due to component failure was assigned to the reported event and analyzed anomalies.
Event or Problem Description
It was reported that the guidewire was broken off during manipulation of the wire.A snare was used to remove the broken wire from the patient's body and a new guidewire was used to complete the procedure.There was no clinical consequence to the patient due to the reported 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: 7783658
• Report Number: 3008880413-2018-00066
• Device Sequence Number: 19271880
• Product Code: DQX
• UDI-Device Identifier: 04546540688774
• UDI-Public: 04546540688774
• 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): 09/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/23/2021
• Device Catalogue Number: M00326420
• Device Lot Number: 0000007773
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2018
• Initial Date Received by Manufacturer: 08/06/2018
• Supplement Date Received by Manufacturer: 09/25/2018
• Initial Report FDA Received Date: 08/14/2018
• Supplement Report FDA Received Date: 09/27/2018
• 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: SL-10 MICROCATHETER (STRYKER)
• Outcome Attributed to Adverse Event: Other; Required Intervention