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

Model Number	SSUP300PRE
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the coil embolization procedure, physician felt resistance in the distal end while operating the subject guidewire.When the subject guidewire was removed to insert the coil it was confirmed that the 4cm tip of the subject guidewire was detached and left inside the patient's anatomy.An attempt was made to retrieve the tip but was difficult so it was embolized with the coils.Patient's anatomy was very meandering.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during the coil embolization procedure, physician felt resistance in the distal end while operating the subject guidewire.When the subject guidewire was removed to insert the coil it was confirmed that the 4cm tip of the subject guidewire was detached and left inside the patient's anatomy.An attempt was made to retrieve the tip but was difficult so it was embolized with the coils.Patient's anatomy was very meandering.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added.D4 expiration 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.It was reported that resistance was felt when operating the subject guidewire and when it was removed, it was confirmed that 4cm of the guidewire tip had detached.An attempt was made to retrieve it; however, it was found to be difficult and the physician ended up coiling and placing the coil as it was.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, flush was given inside the microcatheter when the guidewire was inserted, the introducer was used when inserting the guidewire, there was no allegation against the microcatheter used in the case, and the patient's anatomy was very meandering.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 and the device was not returned, an assignable cause of undeterminable was assigned to this complaint of guidewire distal tip broken/fractured during use, un-retrieved device fragments and guidewire distal end friction.

• Brand Name: SYNCHRO SELECT-14 SUPPORT PS 300CM
• 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: 14417784
• Report Number: 3012931345-2022-00099
• Device Sequence Number: 5301617
• Product Code: MOF
• UDI-Device Identifier: 07613327508642
• UDI-Public: 07613327508642
• 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): 08/06/2022

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: SSUP300PRE
• Device Catalogue Number: SSUP300PRE
• Device Lot Number: 0000063351
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/18/2022
• Supplement Date Received by Manufacturer: 07/13/2022
• Initial Report FDA Received Date: 05/17/2022
• Supplement Report FDA Received Date: 08/06/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown