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

Catalog Number	M00326010
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is 1 of 2 reports (1st mdr) h3 other text : the device is not available to the manufacturer.
Event or Problem Description
It was reported that during mca (middle cerebral artery) m3 aneurysm embolization case.Used subject guidewire to deliver inside microcatheter.The patient's vessel was quite thin and it was hard to be super selected and the operator rotated the subject guidewire again and again and then distal of the subject guidewire was fractured during use.The physician 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 mca (middle cerebral artery) m3 aneurysm embolization case.Used subject guidewire to deliver inside microcatheter.The patient's vessel was quite thin and it was hard to be super selected and the operator rotated the subject guidewire again and again and then distal of the subject guidewire was fractured during use.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
This is 1 of 2 reports (1st mdr).Due to the automated mes (manufacturing execution system) system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not 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.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause and the device was not returned, an assignable cause of undeterminable was assigned.

• Brand Name: SYNCHRO2-14 SOFT 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
• 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: 17882810
• Report Number: 3012931345-2023-00219
• Device Sequence Number: 15276185
• Product Code: DQX
• UDI-Device Identifier: 04546540688729
• UDI-Public: 04546540688729
• 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): 11/08/2023

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: 10/12/2025
• Device Catalogue Number: M00326010
• Device Lot Number: 0000190561
• 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: Not provided
• Supplement Date Received by Manufacturer: 10/26/2023
• Initial Report FDA Received Date: 10/05/2023
• Supplement Report FDA Received Date: 11/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2022
• 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: ATLAS STENT (STRYKER); SL-10 CATHETER (STRYKER); SYNCHRO 10 GUIDEWIRE (STRYKER); SYNCHRO 2 GUIDEWIRE (STRYKER)
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Race: Asian