MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO2-14 SUPPORT PRE-SHAPED 215CM; WIRE, GUIDE, CATHETER

Model Number	S2SPP14215
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/26/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during onyx embolization procedure of a arteriovenous fistula, the distal end of the subject guidewire broke off inside the patient.The subject guidewire tip remains inside the patient and it was embolized into the fistula.The procedure was completed successfully.No snare device was used and the patient was doing well.No additional information is available.
Additional Manufacturer Narrative
The device history record (dhr) confirms that the device met all material, assembly, and performance specifications.During the visual inspection, the guidewire was found kinked bent in various locations.The guidewire ptfe coating was noted to be peeled off.The distal tip of the guidewire was noted to be broken/fractured.The functional inspection was not required.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.Additional information provided by the customer indicated that the device was prepared as per the dfu, that continuous flush was maintained, there was no resistance encountered when removing the guidewire from the dispenser hoop.There were no other difficulties encountered during the usage of the device that could have contributed to the issue, and there was no resistance encountered during the manipulation of the guidewire.It was unknown how tortuous the patient¿s anatomy was.The distal tip of the wire broke inside the patient and was embolized into fistula.There were no adverse consequences.Analysis of the returned device found the guidewire was kinked, the distal tip was broken/fractured and remains inside the patient embolized into the fistula and ptfe peeling was noted on the returned guidewire.It is most likely the ptfe coating was damaged due to interaction with an accessory device, or with another device, however this cannot be confirmed as neither the torque device nor the introducer were returned for analysis.An assignable cause of procedural factors will be assigned to the as reported and as analyzed 'guidewire distal tip broken/fractured during use' and 'un-retrieved device fragment¿ in addition to the as analyzed ¿guidewire kinked/bent¿ and 'guidewire ptfe coating peeling' 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 during onyx embolization procedure of a arteriovenous fistula, the distal end of the subject guidewire broke off inside the patient.The subject guidewire tip remains inside the patient and it was embolized into the fistula.The procedure was completed successfully.No snare device was used and the patient was doing well.No additional information is available.

• Brand Name: SYNCHRO2-14 SUPPORT PRE-SHAPED 215CM
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• Manufacturer (Section G): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 12533143
• Report Number: 3012931345-2021-00158
• Device Sequence Number: 1140158
• Product Code: DQX
• UDI-Device Identifier: 07613327459654
• UDI-Public: 07613327459654
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• 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): 12/02/2021

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: 07/06/2024
• Device Model Number: S2SPP14215
• Device Catalogue Number: S2SPP14215
• Device Lot Number: 0000067173
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/07/2021
• Supplement Date Received by Manufacturer: 11/09/2021
• Initial Report FDA Received Date: 09/27/2021
• Supplement Report FDA Received Date: 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown