MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO2-14 SUPPORT STRAIGHT 300CM; WIRE, GUIDE, CATHETER

Model Number	S2SPS14300
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Hemorrhagic Stroke (4417)
Date of Event	11/22/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during an angioplasty procedure while advancing the subject guidewire through the balloon catheter in the carotid siphon, physician noticed a kink and on removal the tip of the subject guidewire was fractured.He attempted to remove the fragment using multiple stent retrievers and a snare devices but was unsuccessful.The broken fragment was reported stented against the vessel wall so it was unable to retrieved.The patient suffered a subarachnoid hemorrhage.It was not clear that the event was a direct result of the broken subject guidewire.The patient's anatomy was very tortuous and there was a surgical delay of 2 hours.The procedure was not completed and the patient passed away.
Event or Problem Description
It was reported that during an angioplasty procedure while advancing the subject guidewire through the balloon catheter in the carotid siphon, physician noticed a kink and on removal the tip of the subject guidewire was fractured.He attempted to remove the fragment using multiple stent retrievers and a snare devices but was unsuccessful.The broken fragment was reported stented against the vessel wall so it was unable to retrieved.The patient suffered a subarachnoid hemorrhage.It was not clear that the event was a direct result of the broken subject guidewire.The patient's anatomy was very tortuous and there was a surgical delay of 2 hours.The procedure was not completed and the patient passed away.
Additional Manufacturer Narrative
¿ h4 manufacturing date ¿ added.¿ d4 expiration date - added.¿ c2/d10 concomitant products - update.There are controls in the manufacturing process to ensure the product met specifications upon release.Visual and functional inspection were not performed because the product was not returned for investigation.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.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 device was used for icad treatment with stent and balloon catheter, the guidewire tip was shaped 45-60 degrees, the patient's anatomy was very tortuous, friction/resistance was encountered upon withdrawal of the guidewire, and there was a kink approximately 3cm from the distal tip where it ended up fracturing.It was also noted that while trying to navigate the guidewire, a lot of torque was used to get the guidewire to track and the distal end broke off when the physician tried withdrawing the guidewire.An assignable cause of procedural factors will be assigned to this complaint since the issue is associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu but performance was limited due to procedural and/or anatomical factors during use.

• Brand Name: SYNCHRO2-14 SUPPORT STRAIGHT 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: 13019907
• Report Number: 3012931345-2021-00212
• Device Sequence Number: 11947389
• Product Code: DQX
• UDI-Device Identifier: 07613327459647
• UDI-Public: 07613327459647
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K053268
• 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): 03/21/2022

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: 04/18/2024
• Device Model Number: S2SPS14300
• Device Catalogue Number: S2SPS14300
• Device Lot Number: 0000062615
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2021
• Supplement Date Received by Manufacturer: 02/21/2022
• Initial Report FDA Received Date: 12/16/2021
• Supplement Report FDA Received Date: 03/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2021
• 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: EMBOTRAP STENT RETRIEVER ( CERENOVUS); GATEWAY BALLOON CATHETER (STRYKER); MICROCATHETER (UNKNOWN); SNARE (UNKNOWN); STENT RETRIEVER (UNKNOWN); TREVO NXT STENT RETRIEVER (STRYKER); WINGSPAN STENT (STRYKER)
• Outcome Attributed to Adverse Event: Other; Required Intervention; Death
• Patient Sex: Unknown