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

Catalog Number	M00326510
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.During visual inspection the guidewire was noted to be broken/fractured at 292cm from the proximal end.The core wire distal end was observed through the distal tip dome.Functional testing 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.The reported complaint was confirmed based on analysis of the returned device.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.It was reported that while the operator tried to deliver the subject guidewire to go into the microcatheter to pass the treatment site, the operator tried to adjust the guidewire to pass however, the tip of the guidewire was found to be kinked.Additional information provided by the customer indicated that the device was prepared for use as per the directions for use.There was no damage noted to the packaging prior to opening the packaging.The device was confirmed to be in good condition during preparation/prior to use on the patient.The continuous flush was set up and maintained throughout the clinical procedure.The device was returned for analysis, and it was noted that the guidewire was noted to be broken/fractured at 292 cm from the proximal end.The core wire distal end was observed through the distal tip dome.The reported event of the guidewire distal end/tip kinked/bent could not be replicated however, the analysis results are consistent with the reported event and will be assigned a probable cause of handling damage.The analyzed damage of the guidewire broken/fractured during use will be assigned a probable cause of handling damage because this complaint appears to be associated with handling of the product or portion of the product during the procedure.
Event or Problem Description
The device was returned for analysis and the investigation of the device revealed that the guidewire (subject device) was broken/fractured during use.No clinical consequences were reported to the patient due to this event.

• Brand Name: SYNCHRO2-14 STANDARD 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: 20624084
• Report Number: 3012931345-2024-00195
• Device Sequence Number: 8792927
• Product Code: DQX
• UDI-Device Identifier: 04546540688781
• UDI-Public: (01)04546540688781(17)270118(10)0000610645
• 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
• Report Date (Section B): 11/06/2024

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 Catalogue Number: M00326510
• Device Lot Number: 0000610645
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2024
• Initial Report FDA Received Date: 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2024
• 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
• Patient Sex: Unknown
• Patient Race: Asian