MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO-14 STRAIGHT 300-35CM; WIRE, GUIDE, CATHETER

Catalog Number	M00313310
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an intracranial atherosclerosis disease (icad) procedure, the subject guidewire was used to super selected the stenosis lesion.The patient's vessel was extremely tortuous and diffuse calcification; therefore, the subject guidewire was hard to be advanced.The operator decided to finish the procedure directly but when retracting the subject guidewire, it was fractured about 15cm.The operator tried to use a snare device to retrieve the fractured fragment but the vessel was too tortuous so the operator was afraid it may result in other complication so after evaluation the operator decided not to take the fractured guidewire out and finished the procedure.There was a surgical delay of 30 minutes.Based on the physician¿s opinion, the patient's vessel was very tortuous as the subject guidewire fractured was anticipated.The current condition of the patient is good and there were no clinical consequences to the patient.
Additional Manufacturer Narrative
D4 gtin: corrected to (b)(4).G4 pma/510(k): corrected to k002907.There are controls in the manufacturing process to ensure the product met specifications upon release.The subject guidewire device is not available; therefore, a visual inspection as well as a functional evaluation could not be performed.The reported event cannot be confirmed and it cannot be confirmed that the device met specification, as the device was not returned.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 the operator used the subject guidewire to super selected the stenosis lesion.The patient's vessel was extremely tortuous and diffuse calcification so the guidewire was hard to be advanced.The operator decided to finish the procedure directly but when retracting the subject guidewire , the subject guidewire got fractured for about 15cm.The operator tried to use snare to catch the fractured guidewire but the vessel was too tortuous so the operator was afraid it may result in other complication so after evaluation the operator decided not to take the fractured guidewire out and finished the procedure.Additional information received identified that the patient's anatomy was severely tortuous and there was some resistance encountered when rotating, the subject guidewire was torqued 3-4 times.It is probable that the subject guidewire experienced difficulties during navigation through the patient's tortuous anatomy, which may have led to difficulties while torqueing the guidewire and subsequent the subject guidewire fracture.An assignable cause of procedural factors will be assigned to the reported event, 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 atherosclerosis disease (icad) procedure, the subject guidewire was used to super selected the stenosis lesion.The patient's vessel was extremely tortuous and diffuse calcification; therefore, the subject guidewire was hard to be advanced.The operator decided to finish the procedure directly but when retracting the subject guidewire, it was fractured about 15cm.The operator tried to use a snare device to retrieve the fractured fragment but the vessel was too tortuous so the operator was afraid it may result in other complication so after evaluation the operator decided not to take the fractured guidewire out and finished the procedure.There was a surgical delay of 30 minutes.Based on the physician¿s opinion, the patient's vessel was very tortuous as the subject guidewire fractured was anticipated.The current condition of the patient is good and there were no clinical consequences to the patient.

• Brand Name: SYNCHRO-14 STRAIGHT 300-35CM
• 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: 20181234
• Report Number: 3012931345-2024-00167
• Device Sequence Number: 20881977
• Product Code: DQX
• UDI-Device Identifier: 07613252186946
• UDI-Public: (01)07613252186946(17)250705(10)0000452591
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K002907
• 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): 11/14/2024

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: 07/05/2025
• Device Catalogue Number: M00313310
• Device Lot Number: 0000452591
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/20/2024
• Supplement Date Received by Manufacturer: 10/24/2024
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/07/2023
• 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: SL-10 MICROCATHETER (STRYKER).
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 61 YR
• Patient Sex: Unknown
• Patient Race: Asian