MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO2-14 SUPPORT STRAIGHT 300CM; WIRE, GUIDE, CATHETER

Model Number	S2SPS14300
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during an acute thrombus thrombectomy procedure, when the subject guidewire was inserted into the patients anatomy, it could not be rotated.The operator withdrew the subject guidewire and found 5cm from the distal tip was stretched and fractured.The operator replaced it with a new device and continued the procedure without clinical consequences to the patient.
Event or Problem Description
It was reported that during an acute thrombus thrombectomy procedure, when the subject guidewire was inserted into the patients anatomy, it could not be rotated.The operator withdrew the subject guidewire and found 5cm from the distal tip was stretched and fractured.The operator replaced it with a new device and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
There are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, functional testing as well as visual testing cannot be performed.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.Although the device was not returned, the reported complaint was confirmed based on the photo attached to the communication log which showed the guidewire nitinol hypotube was fractured and the platinum wire was stretched.Additional information provided by the customer indicated that the device was confirmed to be in good condition during preparation/prior to use on the patient and was prepared for use as per the dfu, continuous flush was set up and maintained throughout the clinical procedure, the patient's anatomy was moderately tortuous, the guidewire tip was shaped about 90°, there was no friction/resistance encountered during the procedure, a non-stryker microcatheter was used in the procedure, and the guidewire was found to be stretched and fractured 5cm from the distal end when it was withdrawn from the patient.While there are a number of potential causes for the reported issue, because review of available information failed to identify a definitive cause and the device was not returned for analysis, an assignable cause of undeterminable was assigned to this complaint.

• Brand Name: SYNCHRO2-14 SUPPORT STRAIGHT 300CM
• 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: 17045421
• Report Number: 3012931345-2023-00113
• Device Sequence Number: 5044411
• Product Code: DQX
• UDI-Device Identifier: 07613327459647
• UDI-Public: 07613327459647
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 07/07/2023

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: 06/05/2025
• Device Model Number: S2SPS14300
• Device Catalogue Number: S2SPS14300
• Device Lot Number: 0000140967
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/26/2023
• Supplement Date Received by Manufacturer: 06/19/2023
• Initial Report FDA Received Date: 06/01/2023
• Supplement Report FDA Received Date: 07/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: REBAR 18 MICROCATHETER (MEDTRONIC)
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Race: Asian