MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO2-14 STANDARD PRE-SHAPED 200CM; WIRE, GUIDE, CATHETER

Model Number	M00326420
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is not available to manufacturer.
Event or Problem Description
It was reported that the guidewire (subject device) broke off inside the patient's anatomy and it got stuck in the dissection.The physician was not able to find the true lumen of the subject guidewire.No further information about patient's clinical and health consequences is available at the moment.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added.H3 device evaluated by mfg ¿updated.H3 summary attached - updated.D4 expiration date - added.D9 product available to stryker ¿ updated.D9 returned to manufacturer on ¿updated.Based on the results of the dhr review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.During visual inspection, the guidewire hydrophilic coating was broken 19.1cm from the proximal end and the core wire was broken inside the hydrophilic coating which indicates the device was subjected to a significant force which caused the device to break.The guidewire hydrophilic coating was examined along its length with wet fingers and the coating was present on the guidewire.The guidewire ptfe coating was examined under magnification and no anomaly was noted.A 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.It is probable the device was damaged during manipulation in the patient.The remaining fragment of the guidewire was not returned as it had gotten stuck in an existing dissection in the carotid interna of the patient.An assignable cause of procedural factors will be assigned to the reported and analyzed events 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.
Event or Problem Description
It was reported that the guidewire (subject device) broke off inside the patient's anatomy and it got stuck in the dissection.The physician was not able to find the true lumen of the subject guidewire.No further information about patient's clinical and health consequences is available at the moment.

• Brand Name: SYNCHRO2-14 STANDARD PRE-SHAPED 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: 11334217
• Report Number: 3012931345-2021-00032
• Device Sequence Number: 3383489
• 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): 05/19/2021

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: 09/17/2023
• Device Model Number: M00326420
• Device Catalogue Number: M00326420
• Device Lot Number: 51705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2021
• Initial Date Received by Manufacturer: 01/25/2021
• Supplement Date Received by Manufacturer: 04/29/2021
• Initial Report FDA Received Date: 02/16/2021
• Supplement Report FDA Received Date: 05/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other