MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO SELECT-14 STANDARD PS 215CM; GUIDE, WIRE, CATHETER, NEUROVASCULATURE

Catalog Number	SSTD215PRE
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Foreign Body In Patient (2687)
Date of Event	06/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
After the acute ischemic stroke (ais) procedure, the physician reported it was possible that a part of the subject guidewire was left in the patients body.During the postoperative computed tomography (ct) scan, it showed high values indicative of a metallic component and contrast scan revealed an obstruction in the anterior communicating artery (aca) the physician stated the subject guidewire manipulation was somewhat aggressive.When the subject guidewire was examined, it appeared the tip was peeling.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
There are controls in the manufacturing process to ensure the product met specifications upon release.The product 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 could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.Additional information states that continuous flush was set up and maintained throughout the clinical procedure, the device was prepared for use as per the directions for use and the device was confirmed to be in good condition during preparation/prior to use on the patient.It was reported that it is possible that a part of synchro was left behind in the body during the acute ischemic stroke (ais) procedure.The middle cerebral artery (mca) obstruction was reopened with only 1 pass of cat 6 aspiration, and the patient had no symptoms and no clinical problems.However, a postoperative computed tomography (ct) scan showed high values suggestive of some metallic component.On final contrast, it was determined that something was plugging the anterior communicating artery (aca) that was not present on the initial contrast.Although no manipulations were performed inside the blood vessel that would cause problems, the synchro manipulation was somewhat aggressive, and the recovered device looked as if the coating on the tip of the synchro was peeling slightly, so if the stuck object was something from the device used, it could be the synchro's material.Polytetrafluoroethylene (ptfe) is known to be prone to damage and peeling due to back loading of the guidewire through the introducer during insertion and also due to interaction with an under tightened torque device.It is unknown if either the introducer or the torque device were used with the guidewire.The information provided indicates that the material left within the patients anatomy was suggestive of a metallic component.The guidewire ptfe coating is not metallic.However, as the device was not returned and the sample not available for analysis it cannot be definitively determined if the issue was caused by the guidewire ptfe coating.An assignable cause of undeterminable will be assigned to the reported guidewire ptfe coating peeling, retrieved device fragments and patient vessel occlusion, as the product was not returned and a review and analysis of all available information fails to indicate an assignable cause or probable assignable cause.
Event or Problem Description
After the acute ischemic stroke (ais) procedure, the physician reported it was possible that a part of the subject guidewire was left in the patients body.During the postoperative computed tomography (ct) scan, it showed high values indicative of a metallic component and contrast scan revealed an obstruction in the anterior communicating artery (aca) the physician stated the subject guidewire manipulation was somewhat aggressive.When the subject guidewire was examined, it appeared the tip was peeling.No clinical consequences were reported to the patient due to this event.

• Brand Name: SYNCHRO SELECT-14 STANDARD PS 215CM
• 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: 19794953
• Report Number: 3012931345-2024-00135
• Device Sequence Number: 12575834
• Product Code: MOF
• UDI-Device Identifier: 07613327508512
• UDI-Public: (01)07613327508512(17)260829(10)0000554188
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 10/21/2024

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: 08/29/2026
• Device Catalogue Number: SSTD215PRE
• Device Lot Number: 0000554188
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/03/2024
• Supplement Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 07/22/2024
• Supplement Report FDA Received Date: 10/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/31/2023
• 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: AXS CATALYST 6 (STRYKER).; OPTIMO BALLOON GUIDE CATHETER (TOKAI).; TREVO TRAK 21 (STRYKER).
• Outcome Attributed to Adverse Event: Other
• Patient Age: 86 YR
• Patient Sex: Female
• Patient Weight: 51 KG
• Patient Race: Asian