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	01/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during basilar artery (ba) occlusion case, when the subject guidewire was used to guide the microcatheter through lesion, even after repeated attempts with the subject guidewire it failed to successfully cross the lesion.Upon removing, it was observed that the subject guidewire tip was kinked.The procedure was completed successfully without any clinical consequences to the patient.The subject guidewire was returned for analysis and the device investigation revealed that the subject guidewire distal tip was found broken during use.
Additional Manufacturer Narrative
There are controls in the manufacturing process to ensure the product met specifications upon release.During visual and microscopic inspection, it was observed that subject guidewire was seen to be kinked/bent.The subject guidewire distal tip was seen to be broken/fractured and kinked/bent.Functional inspection was not carried out due to damage.The reported event is covered in the device direction 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 event catheter has difficulty tracking over guidewire could not be replicated during device analysis; however, the analysis results are consistent with the reported event.The reported event guidewire distal end/tip kinked/bent was confirmed.The device failed to meet specification when received due to the damage noted.Additional information received indicated that continuous flush was set up and maintained throughout the clinical procedure and the patient's anatomy was moderately tortuous.Friction/resistance was noted at the location of the lesion.The subject device was returned, and it was confirmed that the distal end of the subject guidewire was kinked.It was also noted to have been fractured.There was also kinking noted to the mid-section of the guidewire.It is probable that the guidewire was kinked during the attempt to cross the lesion causing the guidewire to fracture during removal from the patient.An assignable cause of procedural factors will be assigned to the reported events catheter has difficulty tracking over guidewire and guidewire distal end/tip kinked/bent and to the analyzed events guidewire distal tip broken/fractured during use, guidewire distal end/tip kinked/bent and guidewire kinked/bent, 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.

• 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: 22391045
• Report Number: 3012931345-2025-00113
• Device Sequence Number: 8930624
• Product Code: DQX
• UDI-Device Identifier: 04546540688781
• UDI-Public: (01)04546540688781(17)270312(10)0000633360
• 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): 07/02/2025

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: 0000633360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: EXCELSIOR SL-10 MICROCATHETER (STRYKER).; GATEWAY BALLOON CATHETER (STRYKER).; GUIDING CATHETER (UNKNOWN).
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Race: Asian