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

Catalog Number	SSTD300STR
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a chronic occlusion opening procedure, physician selected the subject guidewire for superselective catheterization.When the subject guidewire reached the lesion, it was unable to advance through the stenotic segment but could be retracted.The physician felt that the push/pull force transmission through the subject guidewire was abnormal.Thus, for safety reasons withdrew the subject guidewire.Upon withdrawal, it was found that the distal tip of the subject guidewire was fractured, breaking completely apart upon removal.Thus, the subject guidewire was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
D9 product available to stryker: updated d9 returned to manufacturer on: updated h3 device evaluated by mfg: updated.There are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, it was observed that the guidewire was seen to be broken/fractured 291 cm from the proximal.The guidewire distal end was seen to be slightly kinked/bend.The core wire distal end was observed through the distal tip dome.Functional inspection could not be performed due to the damage noted to the guidewire.The reported event is covered in the device direction 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 distal tip broken/fractured during use was confirmed during analysis.The reported device difficulty engaging target vessel and guidewire difficult to advance could not be replicated; however, the analysis results are consistent with the reported event.The device failed to meet specification when received due to the damage noted.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.It was reported that after the guidewire reached the lesion site, it was unable to advance through the stenotic segment but could be retracted.The physician felt that the force transmission through the guidewire was abnormal.For safety reasons, the guidewire was withdrawn back into the microcatheter and then both the microcatheter and the guidewire were removed from the body together.Once outside the body, the guidewire was removed from the microcatheter and was found to be already fractured, breaking completely apart upon removal.Additional information received 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 not tortuous.The device was returned, and it was confirmed that the distal end had been fractured, there was also some kinking noted to the distal end.It is probable that the device may have experienced difficulties in advance and been damaged due to anatomical and/or procedural factors present during the attempt to advance through the stenotic segment.An assignable cause of procedural factors will be assigned to the reported ¿guidewire distal end/tip broken/fractured during use¿, ¿ device difficulty engaging target vessel¿ and ¿ guidewire difficult to advance¿ and to the analysed ¿guidewire distal tip broken/fractured during use¿ and ¿guidewire distal end/tip kinked/bent¿, as the issue is associated with a product that meets company¿s 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.
Event or Problem Description
It was reported that during a chronic occlusion opening procedure, physician selected the subject guidewire for superselective catheterization.When the subject guidewire reached the lesion, it was unable to advance through the stenotic segment but could be retracted.The physician felt that the push/pull force transmission through the subject guidewire was abnormal.Thus, for safety reasons withdrew the subject guidewire.Upon withdrawal, it was found that the distal tip of the subject guidewire was fractured, breaking completely apart upon removal.Thus, the subject guidewire was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: SYNCHRO SELECT-14 STANDARD ST 300CM
• 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: 21822665
• Report Number: 3012931345-2025-00077
• Device Sequence Number: 9281346
• Product Code: MOF
• UDI-Device Identifier: 07613327508505
• UDI-Public: (01)07613327508505(17)271210(10)0000766428
• 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): 06/24/2025

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 Catalogue Number: SSTD300STR
• Device Lot Number: 0000766428
• 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: 03/21/2025
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 04/10/2025
• Supplement Report FDA Received Date: 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2024
• 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: EXCELSIOR SL-10 MICROCATHETER (STRYKER)
• Patient Sex: Unknown
• Patient Race: Asian