MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO SELECT-14 SUPPORT ST 300CM; WIRE, GUIDE, CATHETER, NEUROVASCULATURE

Catalog Number	SSUP300STR
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during stenosis at the distal end of the left internal carotid artery (ica) procedure, the operator delivered intermediate catheter to the c4 segment of the ica.Next, the operator used the subject guidewire to pass through the lesion and advanced it to the m2 segment of the left middle carotid artery (mca).Once the subject guidewire was in position, a rapid-exchange balloon was used for dilation.Post-dilation angiography showed less-than-ideal results, prompting the withdrawal of the balloon.At this point, it was discovered that the tip of the subject guidewire had fractured within the blood vessel.The operator immediately inserted another guidewire with a microcatheter up to the m1 segment of the mca.After withdrawing the subject guidewire, a stent was used to retrieve the fractured guidewire successfully.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Event or Problem Description
It was reported that during stenosis at the distal end of the left internal carotid artery (ica) procedure, the operator delivered intermediate catheter to the c4 segment of the ica.Next, the operator used the subject guidewire to pass through the lesion and advanced it to the m2 segment of the left middle carotid artery (mca).Once the subject guidewire was in position, a rapid-exchange balloon was used for dilation.Post-dilation angiography showed less-than-ideal results, prompting the withdrawal of the balloon.At this point, it was discovered that the tip of the subject guidewire had fractured within the blood vessel.The operator immediately inserted another guidewire with a microcatheter up to the m1 segment of the mca.After withdrawing the subject guidewire, a stent was used to retrieve the fractured guidewire successfully.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
H3 device evaluated by mfg ¿updated.There are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection the guidewire was noted to be kinked/bent to the proximal end.The distal end was noted to be broken along the nitinol tubing and the core and platinum wire at 296cm.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 event: ¿guidewire distal tip broken/fractured during use¿ was confirmed.The device failed to meet specifications when returned for analysis.It was reported that post-dilation angiography showed less-than-ideal results, prompting the withdrawal of the balloon.At this point, it was discovered that the tip of the guidewire had fractured within the blood vessel.The physician immediately inserted a guidewire with a microcatheter up to the m1 segment of the middle carotid artery (mca).After withdrawing the guidewire, a stent was used to attempt to retrieve the fractured guidewire.After several attempts, the fractured wire was successfully removed.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, continuous flush was set up and maintained throughout the clinical procedure and the patient¿s anatomy was moderately tortuous.The guidewire tip was shaped 60 degrees, the wire was torqued to overcome the resistance and the high tortuosity and where was that tortuosity located was relative to the tip of the guidewire.The device was returned and it was confirmed that the guidewire distal end had fractured, there was also kinking noted to the proximal end of the guidewire.It is probable that the guidewire was fractured as it was torqued to overcome resistance.As per the dfu: " never advance, auger, withdraw, or torque a guidewire which meets resistance.Resistance may be felt and/or observed under fluoroscopy by noting any buckling or prolapse of the guidewire tip.Excessive force against resistance may result in damage to the guidewire, such as separation of the guidewire tip, damage to the interventional device, and/or vessel perforation.Determine the cause of the resistance under fluoroscopy and take any necessary remedial action".An assignable cause of procedural factors will be assigned to the reported and analyzed event: ¿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.The kink to the proximal end of the guidewire is likely due to handling of the device during the clinical procedure, therefore an assignable cause of handling damage will be assigned to the analyzed event: ¿guidewire kinked/bent¿.

• Brand Name: SYNCHRO SELECT-14 SUPPORT ST 300CM
• Common Device Name: WIRE, GUIDE, 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: 21540101
• Report Number: 3012931345-2025-00055
• Device Sequence Number: 15387369
• Product Code: MOF
• UDI-Device Identifier: 07613327508628
• UDI-Public: (01)07613327508628(17)260919(10)0000560980
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 06/02/2025

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: 09/19/2026
• Device Catalogue Number: SSUP300STR
• Device Lot Number: 0000560980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2025
• Supplement Date Received by Manufacturer: 05/12/2025
• Initial Report FDA Received Date: 03/06/2025
• Supplement Report FDA Received Date: 06/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2023
• 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: BALLOON (UNKNOWN).; INTERMEDIATE CATHETER (UNKNOWN).; SOLITAIRE STENT (NON-STRYKER).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Unknown
• Patient Race: Asian