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

Catalog Number	SSUP215STR
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3 other text : the device is not available to the manufacturer.
Event or Problem Description
It was reported that during left middle cerebral artery (mca) stenosis case, resistance was encountered when subject guidewire was used to deliver balloon catheter.While doing so, distal tip of the subject guidewire got fractured and the fractured segment which remained in patient¿s body was tried to retrieve using a snare device but failed.Then, it could be successfully removed using thrombus retriever.There were no clinical consequences to the patient reported as a result of this event and the procedure was completed successfully.
Event or Problem Description
It was reported that during left middle cerebral artery (mca) stenosis case, resistance was encountered when subject guidewire was used to deliver balloon catheter.While doing so, distal tip of the subject guidewire got fractured and the fractured segment which remained in patient¿s body was tried to retrieve using a snare device but failed.Then, it could be successfully removed using thrombus retriever.There were no clinical consequences to the patient reported as a result of this event and the procedure was completed successfully.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added h3 device evaluated by mfg ¿updated h3 summary attached - updated d4 expiration date - added d9 / h3 product available to stryker ¿ updated d9 returned to manufacturer on ¿updated.There are controls in the manufacturing process to ensure the product met specifications upon release.During visual and microscopic inspection, it was observed that the subject guidewire was returned in two fragments at 210cm proximal and 4.5cm distal.The proximal and distal segment of the subject guidewire was found to be broken along the nitinol tubing with the core and platinum wire exposed and the platinum wire stretched.The core wire distal end was observed through the distal tip dome.Functional testing could not be performed due to damage to subject guidewire.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 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 average, the subject guidewire tip was shaped, the introducer was used when inserting the subject guidewire, and resistance was encountered at the distal part of the subject guidewire during the procedure.The subject guidewire was returned broken in two fragments at 210cm proximal and 4.5cm distal.During visual inspection, the nitinol tubing was found to be broken/fractured on the proximal and distal fragments with the core wire slightly exposed on the proximal fragment and the core wire and platinum wire exposed on the distal fragment.The platinum wire was noted to be stretched.Based on the visual inspection and information provided in the complaint, it is probable that the subject guidewire encountered tension and/or torsion forces at the distal tip due to advancing the device against resistance causing it to fracture.The stretching of the platinum coil observed during analysis is a by product of the fracture.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 distal end friction' and the as analyzed 'guidewire distal tip stretched' 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.

• Brand Name: SYNCHRO SELECT-14 SUPPORT ST 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: 18815142
• Report Number: 3012931345-2024-00036
• Device Sequence Number: 8308346
• Product Code: MOF
• UDI-Device Identifier: 07613327508611
• UDI-Public: 07613327508611
• 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): 04/08/2024

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: 07/19/2026
• Device Catalogue Number: SSUP215STR
• Device Lot Number: 0000506689
• 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: 02/13/2024
• Supplement Date Received by Manufacturer: 03/22/2024
• Initial Report FDA Received Date: 03/01/2024
• Supplement Report FDA Received Date: 04/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2023
• 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: 4 MM SNARE (UNKNOWN).; AXS CATALYST 5 CATHETER (STRYKER).; EMBOTRAP STENT RETRIEVER (JOHNSON & JOHNSON).; GATEWAY BALLOON CATHETER (STRYKER).
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Female