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

Catalog Number	S2SPS14215
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There are controls in the manufacturing process to ensure the product met specifications upon release.The device was returned, and the lot number was confirmed with the packaging returned with the device.During visual inspection, the guidewire was returned in 2 fragments (proximal 209.5 cm and distal 6 cm).The guidewire was seen to be slightly kinked at roughly 191 cm from the proximal end.The proximal end was seen to be fractured along the nitinol tubing with the platinum wire stretched.The distal end was seen to be broken along nitinol tubing with the platinum wire stretched.The core wire distal end was observed through the distal tip dome.Functional testing was not completed due to device condition.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 as reported event of guidewire difficult to advance could not be duplicated; however, the analysis results are consistent with the reported event.It is probable the clot is what caused the difficulty as noted in the event description.The guidewire distal tip stretched was confirmed during analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.Additional information provided by the customer stated while crossing through a clot the guidewire got stuck.The patient anatomy had a lot of stenosis.It is probable the patient's anatomy contributed to the event.During analysis the guidewire was returned in 2 fragments, it was slightly kinked at 191 cm from the proximal end, possibly due to anatomy.The distal end was fractured with the platinum wire exposed and stretched.The functional test was unable to be performed due to damage.An assignable cause of procedural factors will be assigned to the as reported events of guidewire difficult to advance and guidewire distal tip stretched as these defects appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use.An assignable cause of procedural factors will be assigned to the as analyzed events of guidewire distal tip stretched, guidewire kinked/bent and guidewire distal tip broken/fractured during use as these defects appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use.
Event or Problem Description
The guidewire (subject device) was returned for analysis and the device investigation revealed that the distal tip of the guidewire (subject device) was fractured during use.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.

• Brand Name: SYNCHRO2-14 SUPPORT STRAIGHT 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: 19292581
• Report Number: 3012931345-2024-00083
• Device Sequence Number: 8966164
• Product Code: DQX
• UDI-Device Identifier: 07613327459630
• UDI-Public: 07613327459630
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Report Date (Section B): 05/10/2024

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 Expiration Date: 09/30/2026
• Device Catalogue Number: S2SPS14215
• Device Lot Number: 0000564976
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/08/2024
• Initial Report FDA Received Date: 05/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2023
• 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: MICROCATHETER (UNKNOWN).
• Patient Sex: Unknown