MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO SELECT-14 SOFT PS 215CM; GUIDE, WIRE, CATHETER, NEUROVASCULATURE

Model Number	SSFT215PRE
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, resistance was encountered when advancing the subject guidewire within a microcatheter and when it was retrieved the distal of the subject guidewire was found to be broken.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 the procedure, resistance was encountered when advancing the subject guidewire within a microcatheter and when it was retrieved the distal of the subject guidewire was found to be broken.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
There are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the guidewire was returned in two fragments.The guidewire was noted to be kinked bent.The guidewire polytetrafluoroethylene (ptfe) coating was seen to be peeling from the proximal end of the guidewire.The proximal fragment was inspected and the nitinol tubing was broken/fractured with the core wire exposed and broken.The distal fragment was inspected and the nitinol tubing was seen to be broken.The core wire distal end was observed through the distal tip dome.Functional inspection 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 guidewire difficult to advance could not be confirmed/replicated due to the damaged device; however, the analysis results are consistent with the reported event.The reported guidewire distal tip broken/fractured during use was confirmed based on the 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.Additional information provided by the customer indicated that the device was confirmed to be in good condition during preparation/prior to use on the patient and was prepared for use as per the dfu, continuous flush was set up and maintained throughout the clinical procedure, the tortuosity of the patient's anatomy was very meandering, the guidewire tip was shaped 45 degrees, the introducer was used when inserting the guidewire, the model and inner diameter of the microcatheter used in the procedure was unknown, and the broken guidewire was completely removed from the microcatheter and patient.The procedure was completed successfully using the same microcatheter and a non-stryker guidewire.Based on the analysis and information provided, it is probable that due to tortuous (meandering) anatomy, the guidewire experienced high tension and/or torsion forces during manipulation in the microcatheter that caused it to fracture at the distal end.An assignable cause of procedural factors will be assigned to the as reported and as analyzed 'guidewire distal tip broken/fractured during use', the as reported 'guidewire difficult to advance' as well as the as analyzed 'guidewire kinked/bent' since these issues are 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 and/or anatomical factors during use.The ptfe coating damage most likely occurred as a result of interaction with an accessory device.The damage noted is consistent with backloading the proximal end of the guidewire into the distal end of the introducer and pulling it through the introducer at an angle.An assignable cause of handling damage will be assigned to the as analyzed 'guidewire ptfe coating peeling' since this issue appears to be associated with handling of the product or portion of the product during the clinical procedure, upon removal of the product from the packaging, or preparation of the product prior to use.

• Brand Name: SYNCHRO SELECT-14 SOFT PS 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: 17360765
• Report Number: 3012931345-2023-00164
• Device Sequence Number: 20135083
• Product Code: MOF
• UDI-Device Identifier: 07613327508598
• UDI-Public: 07613327508598
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K202522
• 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): 08/29/2023

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: 12/25/2025
• Device Model Number: SSFT215PRE
• Device Catalogue Number: SSFT215PRE
• Device Lot Number: 0000210826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/28/2023
• Supplement Date Received by Manufacturer: 08/25/2023
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 08/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/27/2022
• 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: MICROCATHETER (UNKNOWN)
• Patient Sex: Unknown