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

Model Number	SSTD215PRE
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that dual catheter tanique was used for dural-avf (arteriovenous fistula) intracranial coil embolization procedure in patient with very meandering vasculature.During the procedure the catheter in which the coil was inserted migrated from the target site, therefore an attempt was made to place the catheter to its original position with the subject guidewire.But at the tip of the catheter, subject guidewire knuckle like j shaped and when the catheter was pushed forward as it was, the guidewire kinked at the tip of the catheter.When an attempt was made to remove the guidewire, the subject guidewire was ruptured at the kinked part, and the tip of the subject guidewire (about 3 cm) was left inside the aneurysm where coil embolization was performed and it was pushed in coil mass.The surgeon commented that it was not a problem with the device but a problem with the way it was used.The procedure was completed successfully.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 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 there was no damage noted to the packaging prior to opening the packaging, the device was confirmed to be in good condition during preparation/prior to use on the patient, the device was prepared for use as per the directions for use, continuous flush was set up and maintained throughout the clinical procedure and the patient¿s anatomy was very meandering.There was no resistance when the gw was taken out of the dispenser hoop.The gw was not shaped.Flush was given inside the mc at the time when the gw was inserted.There was no friction or resistance felt at the hub, it is unknown if the introducer sheath was used, when inserting the gw.It is unknown what catheter was used during the procedure.Difficulties were encountered after the tip of the gw became j-shaped, when the gw was advanced with the catheter.The anatomy location/vessel name of intended treatment was intracranial blood vessel, dural-avf (arteriovenous fistula).The remnant piece of the guidewire was left in the area that was to be filled with coils, ¿it was pushed in coil mass." while there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause, a cause of undeterminable was assigned for the reported ¿guidewire distal tip poor shape retention¿, ¿guidewire distal end/tip kinked/bent¿, ¿guidewire distal tip broken/fractured during use¿, ¿unretrieved device fragments¿, ¿device interaction with another device¿ and ¿guidewire difficult to advance¿.
Event or Problem Description
It was reported that dual catheter tanique was used for dural-avf (arteriovenous fistula) intracranial coil embolization procedure in patient with very meandering vasculature.During the procedure the catheter in which the coil was inserted migrated from the target site, therefore an attempt was made to place the catheter to its original position with the subject guidewire.But at the tip of the catheter, subject guidewire knuckle like j shaped and when the catheter was pushed forward as it was, the guidewire kinked at the tip of the catheter.When an attempt was made to remove the guidewire, the subject guidewire was ruptured at the kinked part, and the tip of the subject guidewire (about 3 cm) was left inside the aneurysm where coil embolization was performed and it was pushed in coil mass.The surgeon commented that it was not a problem with the device but a problem with the way it was used.The procedure was completed successfully.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: 13435046
• Report Number: 3012931345-2022-00018
• Device Sequence Number: 19915554
• Product Code: MOF
• UDI-Device Identifier: 07613327508512
• UDI-Public: 07613327508512
• 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): 04/25/2022

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: 05/02/2024
• Device Model Number: SSTD215PRE
• Device Catalogue Number: SSTD215PRE
• Device Lot Number: 63332
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/06/2022
• Supplement Date Received by Manufacturer: 03/30/2022
• Initial Report FDA Received Date: 02/03/2022
• Supplement Report FDA Received Date: 04/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2021
• 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: CATHETER (UNKNOWN)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown