MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO-10 STRAIGHT 200CM; WIRE, GUIDE , CATHETER

Model Number	M00316310
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/27/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during one dural arteriovenous fistula case, the distal of guidewire was fractured in the patient's vessel due to the tortuous vessel condition and fragment left inside the patient.Then, finished the procedure successfully by using coils to occlude the related vessel as it was part of the planned procedure.The patient is doing ok and not added on medication due to the vessel occlusion.
Event or Problem Description
It was reported that during one dural arteriovenous fistula case, the distal of guidewire was fractured in the patient's vessel due to the tortuous vessel condition and fragment left inside the patient.Then, finished the procedure successfully by using coils to occlude the related vessel as it was part of the planned procedure.The patient is doing ok and not added on medication due to the vessel occlusion.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added.H3 device evaluated by mfg ¿updated.H3 summary attached - updated.D4 expiration date - added.Based on the results of the device history record (dhr) review, there is no indication that the device, labeling, or packaging failed to meet its specifications when released.During visual inspection, the guidewire was noted to be kinked approximately 197cm from the proximal end, the guidewire nitinol tubing was broken approximately 199.5cm from the proximal end, the hydrophilic coating was hydrated, and the coating was present, the remaining distal end of the guidewire was not returned, and the guidewire ptfe coating was examined under magnification and peeling was noted approximately 24cm and 31cm from the proximal end.Functional test was not required as the defect was visually confirmed.The event was confirmed based on the damage noted to the returned device.The device failed to meet specification when returned for analysis.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.An assignable cause of procedural factors will be assigned to the reported and analyzed ¿guidewire distal tip broken/fractured during use¿ and ¿un-retrieved device fragments¿, in addition to the as analyzed ¿guidewire distal end kinked/bent¿ as the issue is associated with a product 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.The proximal end of the returned device found the ptfe coating was peeled/scraped off approximately 24cm and 31cm from the proximal end.It is most likely the ptfe coating was damaged due to the torque device being insecurely fastened causing it to drag down the wire during use however this cannot be confirmed as the torque device was not returned.Therefore, a cause of 'undeterminable' has been assigned to the as analyzed ¿guidewire ptfe coating peeling'.

• Brand Name: SYNCHRO-10 STRAIGHT 200CM
• Common Device Name: WIRE, GUIDE , CATHETER
• Manufacturer (Section D): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• MDR Report Key: 12014284
• Report Number: 3012931345-2021-00096
• Device Sequence Number: 4205034
• Product Code: DQX
• UDI-Device Identifier: 07613252187158
• UDI-Public: 07613252187158
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K032146
• 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): 09/22/2021

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: 02/21/2023
• Device Model Number: M00316310
• Device Catalogue Number: M00316310
• Device Lot Number: 0000059210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2021
• Initial Date Received by Manufacturer: 05/28/2021
• Supplement Date Received by Manufacturer: 09/20/2021
• Initial Report FDA Received Date: 06/17/2021
• Supplement Report FDA Received Date: 09/23/2021
• 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: EV3 MICROCATHETER (MERIT MEDICAL SYSTEMS); VISSE COILS (UNKNOWN MANUFACTURER); EV3 MICROCATHETER (MERIT MEDICAL SYSTEMS); VISSE COILS (UNKNOWN MANUFACTURER)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 36 YR
• Patient Weight: 65