MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO-10 STRAIGHT 200CM; WIRE, GUIDE, CATHETER

Model Number	M00316310
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available.
Event or Problem Description
It was reported that during the procedure the guidewire (subject device) became detached in the patient, and a portion is still stuck in patient.No further information is available.
Event or Problem Description
It was reported that during the procedure the guidewire (subject device) became detached in the patient, and a portion is still stuck in patient.No further information is available.Additional information received stated that when the physician was navigating the microcatheter in the left occipital artery, they lost pushability of the subject guidewire.When the subject guidewire was pulled back, the physician noticed part of the subject guidewire broke off in the left occipital artery.Multiple attempts were made to remove the broken guidewire with a snare and occlusion balloon, however, the guidewire was not removed and is currently still in the left occipital artery off the left external carotid.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added.D4 expiration date - added.D10 concomitant product grid- updated.A2 age- added.A3 gender- added.A4 weight- added.A6 race- added.B2 outcomes attributed to ae- updated.B5 executive summary- updated.H6 health impact code- updated.There are controls in the manufacturing process to ensure the product met specifications upon release.Visual and functional inspections were not performed as 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 provided by the customer indicated the original intended procedure was embo of left dural av fistula.The additional event description from the medwatch report stated ¿surgeon was navigating with the microcatheter in left occipital artery.Lost pushability of the guidewire.Pulled back the guidewire and noticed part of wire broke off in left occipital artery.It was a tortuous artery.Tried multiple attempts on removing broken wire with the snares and with 7 mm x 7 mm occlusion balloon.Wire was not removed and is currently still in the left occipital artery off the left external carotid.¿ 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 as reported defects ¿un-retrieved device fragments¿ and ¿guidewire broken/fractured during use¿.

• Brand Name: SYNCHRO-10 STRAIGHT 200CM
• 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: 16514558
• Report Number: 3012931345-2023-00038
• Device Sequence Number: 6363500
• Product Code: DQX
• UDI-Device Identifier: 07613252187158
• UDI-Public: 07613252187158
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• 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): 05/25/2023

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: 10/04/2024
• Device Model Number: M00316310
• Device Catalogue Number: M00316310
• Device Lot Number: 0000188068
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/07/2023
• Supplement Date Received by Manufacturer: 04/28/2023
• Initial Report FDA Received Date: 03/09/2023
• Supplement Report FDA Received Date: 05/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2022
• 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: HYPERFORM OCCLUSION BALLOON (MEDTRONIC); MARATHON MICROCATHETER (MEDTRONIC); MONGOOSE SNARES (UNKNOWN)
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Race: White