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

Catalog Number	SSUP215STR
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the procedure, when the surgeon was trying to gain access with the subject guidewire, the distal tip of the wire (approx.The last 6cm) broke off inside the patient in proximal internal carotid artery (ica).The surgeon retrieved the broken portion with a micro snare.The patient was stable during this time but was not kept in a hypertensive state.The surgeon then had to abandon the procedure.No other information was provided.
Additional Manufacturer Narrative
D4 gtin: corrected to (b)(4).There are controls in the manufacturing process to ensure the product met specifications upon release.The subject guidewire device is not available; therefore, a visual inspection as well as a functional evaluation could not be performed.The reported event could not be confirmed and it cannot be determined if the device met specification, as the subject guidewire device 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.It was reported that the distal tip of the subject guidewire broke off in the proximal ica of the patient.A micro snare was used to retriever the fractured guidewire fragment.Whilst the surgeon was trying to gain access with the subject guidewire, the distal tip of the subject guidewire (approx.The last 6cm) broke off and remained inside the patient.The subject guidewire device was not returned and a review of all available information fails to indicated an assignable cause for the reported event, therefore an assignable cause of undeterminable will be assigned to the reported event.
Event or Problem Description
It was reported that during the procedure, when the surgeon was trying to gain access with the subject guidewire, the distal tip of the wire (approx.The last 6cm) broke off inside the patient in proximal internal carotid artery (ica).The surgeon retrieved the broken portion with a micro snare.The patient was stable during this time but was not kept in a hypertensive state.The surgeon then had to abandon the procedure.No other information was provided.

• Brand Name: SYNCHRO SELECT-14 SUPPORT ST 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: 19939711
• Report Number: 3012931345-2024-00142
• Device Sequence Number: 4890604
• Product Code: MOF
• UDI-Device Identifier: 07613327508611
• UDI-Public: (01)07613327508611(17)261014(10)0000571568
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K202522
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2024

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 Catalogue Number: SSUP215STR
• Device Lot Number: 0000571568
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/19/2024
• Supplement Date Received by Manufacturer: 10/02/2024
• Initial Report FDA Received Date: 08/08/2024
• Supplement Report FDA Received Date: 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/16/2023
• 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: SNARE DEVICE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 70 KG