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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is 3 of 3 reports (3rd mdr).The device is not available to the manufacturer.
Event or Problem Description
It was reported that during the basilar artery stenosis procedure, following delivery of the microcatheter to the proximal of the occlusion segment, an attempt was made to deliver the subject guidewire to pass the occlusion.However the distal tip of the subject guidewire was found to be fractured when passing through the occlusion segment.The physician attempted to remove the subject guidewire with the microcatheter but it could not be removed.A balloon catheter was used to reach the fractured section of the subject guidewire and was dilated to catch the subject guidewire and successfully remove it from the patients body.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added.H3 device evaluated by mfg ¿updated.H3 summary attached - updated.D4 expiration date - added.D9 returned to manufacturer on - updated.D9 product available to stryker ¿ updated.There are controls in the manufacturing process to ensure the product met specifications upon release.The device was returned, and the lot number was confirmed with the packaging returned with the device.During visual inspection, guidewire was seen to be fractured at 184cm from the proximal end with the core and platinum wire exposed.The distal tip fragment 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.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.It was reported that after delivering a microcatheter to proximal of the occlusion segment, the operator tried to deliver the subject guidewire to pass the occlusion but after several tries (push and rotate) the operator found the distal of the subject guidewire was not moved with the proximal handling.The operator thought the subject guidewire fractured so he withdrew the microcatheter and guidewire out together.The operator tried to withdraw the subject guidewire out together with microcatheter but the fractured part was not removed together with the microcatheter.So the operator used a balloon to reach the fractured guidewire part and dilated the balloon to catch the subject guidewire between the middle catheter and the balloon and then took it out of patient's body.Additional information provided by the customer indicated continuous flush was set up and maintained throughout the clinical procedure and the patients anatomy was not tortuous.The type of surgery is chronic internal carotid artery occlusion and the wire was torqued to overcome the resistance.The device was returned for analysis and it was confirmed that the distal end of the guidewire had been fractured.The patients anatomy was not tortuous, however there was chronic occlusion to the treatment site, which is likely to have caused difficulties when crossing the occlusion and the device was torqued to overcome the resistance, this is likely to have caused the subject guidewire to fracture.An assignable cause of procedural factors will be assigned to the as reported and analyzed event of 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.This is 3 of 3 reports (3rd mdr).
Event or Problem Description
It was reported that during the basilar artery stenosis procedure, following delivery of the microcatheter to the proximal of the occlusion segment, an attempt was made to deliver the subject guidewire to pass the occlusion.However the distal tip of the subject guidewire was found to be fractured when passing through the occlusion segment.The physician attempted to remove the subject guidewire with the microcatheter but it could not be removed.A balloon catheter was used to reach the fractured section of the subject guidewire and was dilated to catch the subject guidewire and successfully remove it from the patients body.The physician replaced it with a new device and continued the procedure without 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: 19226640
• Report Number: 3012931345-2024-00069
• Device Sequence Number: 8320821
• Product Code: DQX
• UDI-Device Identifier: 07613252186946
• UDI-Public: 07613252186946
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K032146
• 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): 05/22/2024

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: 02/18/2025
• Device Catalogue Number: M00313310
• Device Lot Number: 0000225868
• 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: 04/15/2024
• Supplement Date Received by Manufacturer: 05/16/2024
• Initial Report FDA Received Date: 05/01/2024
• Supplement Report FDA Received Date: 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2023
• 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: GATEWAY BALLOON CATHETER (STRYKER); SL-10 MICROCATHETER (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Race: Asian