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

Catalog Number	S2SPS14215
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Analysis of the returned subject guidewire device revealed that the distal tip of the subject guidewire had been fractured and separated during use.There was no clinical consequence to the patient due to this event.
Additional Manufacturer Narrative
There are controls in the manufacturing process to ensure the product met specifications upon release.A visual inspection was examined, and it was observed that the subject guidewire device was noted to be broken/fractured 210cm from the proximal end, the distal end was not returned.No other anomalies were noted.The functional inspection could not be performed as the guidewire was broken/fractured and the tip was not returned.The reported events could not be replicated during device analysis; however, the analysis results are consistent with the reported event.The device failed to meet specification when returned for analysis, based on the damage noted.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.It was reported that when delivered a subject guidewire device to pass the thrombus, the operator found resistance after reached the occlusion and the subject guidewire device was not able to be advanced.Withdrew the subject guidewire device and it was also hard.After taking the subject guidewire device out and found tip 10cm of the subject guidewire device was stretched.Replaced it with another guidewire to finish the procedure.Additional information provided by the customer indicated that continuous flush set was up and maintained throughout the clinical procedure and the patients anatomy was moderately tortuous.The operator couldn't rotate the guidewire, the guidewire was rotated once.The subject guidewire device was returned for analysis, and it was found that the distal tip of the subject guidewire device had been fractured and separated from the subject guidewire device.The analysis results are consistent with the reported event.It is probable that the subject guidewire device experienced friction and difficulties in advancing and torqueing due to procedural and/or anatomical factors present during the clinical procedure, it is probable that the subject guidewire device then fractured and separated due to the attempt to rotate the subject guidewire device against resistance and removal from the patient.An assignable cause of procedural factors will be assigned to the as reported and as analyzed defects, 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 SUPPORT STRAIGHT 215CM
• Common Device Name: GUIDE, WIRE, CATHETER, NEUROVASCULATURE
• 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: 20893340
• Report Number: 3012931345-2024-00211
• Device Sequence Number: 7783408
• Product Code: MOF
• UDI-Device Identifier: 07613327459630
• UDI-Public: (01)07613327459630(17)261211(10)0000597623
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K190843
• 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): 12/10/2024

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 Catalogue Number: S2SPS14215
• Device Lot Number: 0000597623
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2024
• Initial Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2023
• 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: PRO 18 MICROCATHETER (STRYKER)
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 55 KG
• Patient Race: Asian