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

Model Number	SSUP300STR
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that a vascular dissociation procedure was performed in a patient in intracranial blood vessel to place a stent.Initially during the procedure, resistance was felt when the physician advanced the subject guidewire through the balloon catheter for pre-extension.Later when the stent system was advanced over the subject guidewire, the resistance was so strong that it was determined that the subject guidewire cannot be used anymore because of the positioning accuracy.According to the physician the subject guidewire might have had the coating problem.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
D4 expiration date - added.H4 manufacturing date ¿ added.There are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, functional testing as well as visual testing cannot be performed.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 provided by the customer indicated that the device was confirmed to be in good condition during preparation/prior to use on the patient and was prepared as per the dfu, continuous flush was set up and maintained throughout the clinical procedure, the tortuosity of the patient's anatomy was normal, the provided introducer was used to load the guidewire, the guidewire was shaped 45 degrees, and it was unknown where on the guidewire the coating issue was noted.The same balloon catheter and stent were used to complete the procedure after replacing the subject device with another.While there are a number of potential causes for the reported 'guidewire difficult to advance' and 'guidewire delamination', because review and analysis of available information failed to identify a definitive cause and the device was not returned, an assignable cause of undeterminable was assigned to this complaint.
Event or Problem Description
It was reported that a vascular dissociation procedure was performed in a patient in intracranial blood vessel to place a stent.Initially during the procedure, resistance was felt when the physician advanced the subject guidewire through the balloon catheter for pre-extension.Later when the stent system was advanced over the subject guidewire, the resistance was so strong that it was determined that the subject guidewire cannot be used anymore because of the positioning accuracy.According to the physician the subject guidewire might have had the coating problem.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 SUPPORT ST 300CM
• 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: 13608648
• Report Number: 3012931345-2022-00035
• Device Sequence Number: 11245501
• Product Code: MOF
• UDI-Device Identifier: 07613327508628
• UDI-Public: 07613327508628
• 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): 05/19/2022

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 Expiration Date: 05/03/2024
• Device Model Number: SSUP300STR
• Device Catalogue Number: SSUP300STR
• Device Lot Number: 0000063386
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2022
• Supplement Date Received by Manufacturer: 04/21/2022
• Initial Report FDA Received Date: 02/26/2022
• Supplement Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2021
• 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 MR BALLOON (STRYKER); WINGSPAN STENT (STRYKER)
• Patient Sex: Unknown