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	09/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an intracranial atherosclerotic disease (icad) procedure.The subject guidewire distal tip used by the physician got fractured inside the patient's body without excessive manipulation.The fractured subject guidewire, which remained within the balloon catheter, was successfully retrieved.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
D4 expiration date ¿ added.D4 gtin ¿ added.H4 manufacturing date ¿ added.H3 device evaluated by mfg ¿up0dated.D9 product available to stryker ¿ updated.D9 returned to manufacturer on ¿updated.Based on the results of the dhr (device history record) review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.During visual inspection, approximately 287.9 cm of the subject guidewire was returned.The distal fragment (approximately 12.1cm) was not returned.The nitinol tubing of the returned guidewire was broken/fractured.The nitinol tubing surface was rough as per photos.The core wire was broken/fractured inside the nitinol tubing, and the surface was rough.The 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 complaint was confirmed based on analysis.The device failed to meet specification when received for complaint investigation based on the analyzed anomaly noted to the device.It was reported that ¿during an icad procedure, the subject guidewire used by the physician fractured inside the patient's body without excessive manipulation.The fractured guidewire, which remained within the balloon catheter, was successfully retrieved¿.Additional information provided by the customer did not indicate any issues noted during unpacking or set up of the device, and the device was prepared as per dfu instructions.There was no resistance encountered removing the guidewire from the dispenser hoop.There was no indication of a user related issue.The anatomy was reported to be moderately tortuous.The guidewire tip was shaped about 45°.A balloon from other brand was used in the procedure.The wire was not torqued to overcome the resistance.The issue noted at the distal end of the guidewire.There was no friction/resistance encountered during the procedure and no force was used to overcome resistance.There was not a high tortuosity relative to the tip of the guidewire.There were no other difficulties encountered during the usage of the device that could have contributed to the issue.Analysis of the returned device found approximately 287.9cm of the guidewire was returned, but the distal fragment (approximately 12.1cm) was not returned.The nitinol tubing of the returned guidewire was broken/fractured, and the surface was rough.The core wire was broken/fractured inside the nitinol tubing, and the surface was rough.The damage to the returned guidewire indicates the device encountered a significant force during use.Based on the review of all available information, an assignable cause of procedural factors will be assigned to the as reported ¿guidewire distal tip broken/fractured during use¿ and 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.
Event or Problem Description
It was reported that during an intracranial atherosclerotic disease (icad) procedure.The subject guidewire distal tip used by the physician got fractured inside the patient's body without excessive manipulation.The fractured subject guidewire, which remained within the balloon catheter, was successfully retrieved.The subject device 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: 23127072
• Report Number: 3012931345-2025-00157
• Device Sequence Number: 18002740
• Product Code: MOF
• UDI-Device Identifier: 07613327508505
• UDI-Public: (01)07613327508505(17)280324(10)0000807470
• 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): 11/03/2025

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: 0000807470
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/04/2025
• Supplement Date Received by Manufacturer: 10/14/2025
• Initial Report FDA Received Date: 09/23/2025
• Supplement Report FDA Received Date: 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/26/2025
• 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).
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Weight: 46 KG
• Patient Race: Asian