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

Model Number	SSFT215PRE
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Device Embedded In Tissue or Plaque (3165)
Date of Event	09/24/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is 2 of 2 report.The device is not available to the manufacturer.
Event or Problem Description
It was reported that during endovascular procedure in a patient with basilar artery occlusion, when physician was advancing first guidewire to target lesion, it fractured.Physician then used another second guidewire(subject device) to place a rescue stent to attach first guidewire on the wall of the vessel, but second guidewire(subject device) also fractured.Physician completed the procedure by attaching both the first and second(subject device) wires on the wall with a stent as a medical intervention.Fragment of second guidewire(subject device) remained inside patient's anatomy.After the procedure, the patient had a motor deficit in both limbs.The patient's symptoms recovered, like before the procedure, after 4 days.No other information is available.
Event or Problem Description
It was reported that during endovascular procedure in a patient with basilar artery occlusion, when physician was advancing first guidewire to target lesion, it fractured.Physician then used another second guidewire(subject device) to place a rescue stent to attach first guidewire on the wall of the vessel, but second guidewire(subject device) also fractured.Physician completed the procedure by attaching both the first and second(subject device) wires on the wall with a stent as a medical intervention.Fragment of second guidewire(subject device) remained inside patient's anatomy.After the procedure, the patient had a motor deficit in both limbs.The patient's symptoms recovered, like before the procedure, after 4 days.No other information is available.
Additional Manufacturer Narrative
There are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the guidewire was found to be kinked/bent, the guidewire was returned broken/fractured 202cm from the proximal end, the distal fractured segment was not returned, and the hydrophilic coating was hydrated and there were no anomalies noted.The proximal segment was inspected and noticed that the nitinol tubing was broken in multiple areas, the core wire was visibly broken (distal end of the proximal segment), and the platinum wire was found to be broken/fractured and not visible.A functional inspection was not performed.The reported guidewire broken fractured during use and un-retrieved device fragments were confirmed during the analysis.The reported patient neurological deficit could not be confirmed during the analysis as the issue is procedure/patient related.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.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.Additional information provided by the customer indicated that the device was confirmed to be in good condition prior to use and was prepared as per the dfu, continuous flush was maintained throughout the procedure, the distal tip of the guidewire was shaped in a loose j, the issue was noticed when the wire and sl-10 microcatheter were advanced to the target lesion (distal basilar artery), and the anatomy was not tortuous.During analysis, the guidewire was found to be kinked/bent and was returned broken/fractured at 202cm from the proximal end.The distal fractured segment was not returned.On the proximal segment, the core wire was exposed, and the nitinol tubing was broken in multiple areas.The platinum wire was also noted to be fractured under the nitinol tubing.Based on analysis, it is probable that the guidewire experienced high tension and torsion forces while navigating inside the catheter during the procedure that resulted in the kink along its length and fracture at the distal tip.An assignable cause of procedural factors will be assigned to the reported 'guidewire broken/fractured during use', 'patient neurological deficit' and 'un-retrieved device fragments' and to the analyzed 'guidewire broken/fractured during use', 'un-retrieved device fragments' and 'guidewire kinked/bent' since the 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.

• Brand Name: SYNCHRO SELECT-14 SOFT PS 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: 15655258
• Report Number: 3012931345-2022-00193
• Device Sequence Number: 14067193
• Product Code: MOF
• UDI-Device Identifier: 07613327508598
• UDI-Public: 07613327508598
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 12/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/27/2024
• Device Model Number: SSFT215PRE
• Device Catalogue Number: SSFT215PRE
• Device Lot Number: 0000063064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/26/2022
• Supplement Date Received by Manufacturer: 11/22/2022
• Initial Report FDA Received Date: 10/21/2022
• Supplement Report FDA Received Date: 12/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2021
• 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: ENTERPRISE 2 4.0*30 STENT(NON-STRYKER); ENVOY DA 6F 105CM GUIDE CATHETER(NON-STRYKER); SL-10 45 MICROCATHETER(STRYKER); SYNCHRO SELECT GUIDEWIRE(STRYKER); TRAK21 MICROCATHETER(STRYKER); TRAXCESS GUIDEWIRE(NON-STRYKER); TREVO 3*32 RETRIEVER(SRYKER)
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 67 YR
• Patient Sex: Male