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

Model Number	S2SPS14215
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection an attempt had been made to shape the guidewire tip.The guidewire was noted to be kinked/bent at 202cm from the proximal end.The guidewire was noted to be broken/fractured at 209.5cm from the proximal end.In the proximal segment, the platinum wire was noted to be stretched and the core wire was noted to be exposed.In the distal segment, the platinum wire was noted to be stretched, no core wire was noted to be exposed.The core wire distal end was observed through the distal tip dome.Hydrophilic coating was hydrated there were no anomalies noted.The torque device was not returned.A functional inspection could not be confirmed as the device was damaged and the torque device was not returned.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.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 continuous flush was set up and maintained throughout the clinical procedure, no damage was noted to the packaging prior to opening, the device was confirmed to be in good condition during preparation/prior to use on the patient and was prepared as per the dfu.The patients anatomy was noted to be moderately tortuous.The operator tried to use the torque device to manipulate the guidewire, it was noted that when the torque was tightened the guidewire could not be manipulated.During analysis, the guidewire was noted to be kinked/bent at 202cm from the proximal end, and was noted to be broken/fractured at 209.5cm from the proximal end.In the proximal segment, the platinum wire was noted to be stretched and the core wire was noted to be exposed, and in the distal segment, the platinum wire was noted to be stretched, no core wire was noted to be exposed.The core wire was broken at the fracture point which indicates the guidewire encountered excessive force and manipulation such as bending and torsion during the procedure which resulted in the observed damage.An assignable cause of procedural factors will be assigned to the as reported ¿guidewire torque problem¿ and the as reported/as analysed ¿guidewire distal tip stretched¿ as well as the as analysed ¿guidewire distal tip broken/fractured during use¿ 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.An assignable cause of handling damage will be assigned to the as analysed ¿guidewire kinked/bent¿ as these issues are due to 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.
Event or Problem Description
The guidewire (subject device) was returned for analysis and it was discovered that the guidewire (subject device) distal tip-was broken/fractured during use.The procedure was completed successfully.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: 16454500
• Report Number: 3012931345-2023-00031
• Device Sequence Number: 5860461
• Product Code: DQX
• UDI-Device Identifier: 07613327459630
• UDI-Public: 07613327459630
• 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): 02/28/2023

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: 10/13/2024
• Device Model Number: S2SPS14215
• Device Catalogue Number: S2SPS14215
• Device Lot Number: 0000084517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2023
• Initial Report FDA Received Date: 02/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2021
• 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(STRYKER); TORQUE DEVICE (UNKNOWN)
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Race: Asian