MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO2-14 SUPPORT STRAIGHT 215CM; GUIDE, WIRE, CATHETER, NEUROVASCULATURE

Catalog Number	S2SPS14215
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure for an acute ischemic stroke patient with a calcified clot located at m1, the physician faced resistance when advancing the subject guidewire halfway through the clot.While advancing, the distal tip of the subject guidewire was unable to torque properly and got lodged in the clot area.When the subject guidewire was removed from the microcatheter, the physician observed that the distal tip was stretched partially broken.The procedure was completed successfully by replacing the subject device.No clinical consequences were reported to the patient due to this event.
Event or Problem Description
It was reported that during procedure for an acute ischemic stroke patient with a calcified clot located at m1, the physician faced resistance when advancing the subject guidewire halfway through the clot.While advancing, the distal tip of the subject guidewire was unable to torque properly and got lodged in the clot area.When the subject guidewire was removed from the microcatheter, the physician observed that the distal tip was stretched partially broken.The procedure was completed successfully by replacing the subject device.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
H3 device evaluated by mfg ¿updated.D9 product available to stryker ¿ updated.D9 returned to manufacturer on ¿updated.D4 gtin - corrected.There are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the distal 5.5cm of the nitinol tubing was fractured with stretching to the platinum coil.Functional test was not required due to the fractured wire.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 guidewire distal tip fracture and stretch were confirmed.The reported device difficulty engaging target vessel and torque problem were not replicated, however the damage noted is consistent with the reported event.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.It was reported that this case involved an acute ischemic stroke patient with a calcified clot located at m1.The physician faced resistance when advancing the guidewire halfway through the clot, while advancing the distal tip was unable to torque properly and got lodged in the clot area.When the guidewire was removed from the microcatheter, the physician observed that the distal tip of the synchro2 support guidewire have been stretched but the wire was not completely detached.Additional information provided by the customer states that the inferior division of middle cerebral artery mca was quite tortuous.During analysis the guidewire was returned and confirmed to be stretched with fracture to the nitinol tubing, confirming the reported event.It is probable that the guidewire experienced difficulties to pass through the calcified clot due to the consistency of the calcified clot, this likely caused the guidewire to become difficult to torque and the subsequent fracture and stretch to the guidewire during the attempt to remove the guidewire.An assignable cause of procedural factors will be assigned to the reported events of device difficulty engaging target vessel, guidewire torque problem, guidewire distal tip stretched and guidewire distal tip broken/fractured during use and analyzed defects of guidewire distal tip stretched and guidewire distal tip broken/fractured during use, as these defects appears to be 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 factors during use.

• Brand Name: SYNCHRO2-14 SUPPORT STRAIGHT 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: 20371734
• Report Number: 3012931345-2024-00178
• Device Sequence Number: 6877787
• Product Code: MOF
• UDI-Device Identifier: 07613327459630
• UDI-Public: (01)07613327459630(17)260930(10)0000564976
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K190843
• 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): 12/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2026
• Device Catalogue Number: S2SPS14215
• Device Lot Number: 0000564976
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/10/2024
• Supplement Date Received by Manufacturer: 11/18/2024
• Initial Report FDA Received Date: 10/04/2024
• Supplement Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2023
• 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: HEADWAY 21 MICROCATHETER (NON-STRYKER).; SOLITAIRE 4MM STENT (NON-STRYKER).
• Patient Sex: Unknown