MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO2-14 SOFT STRAIGHT 200CM; WIRE, GUIDE, CATHETER

Catalog Number	M00326010
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the acute left middle cerebral artery occlusion procedure, the physician prepared to do in situ stenosis.Physician used a slim guidewire and multiple angiography catheter to bring delivery catheter to left internal carotid artery and exchanged with distal access catheter.Physician used the subject guidewire to bring the microcatheter to internal carotid artery c6.However, the subject guidewire could not be manipulated to advance.Digital subtraction angiography showed the tip of subject guidewire fractured in c6, so the physician withdrew the microcatheter but couldn't see the fractured tip.Physician then advanced the distal access catheter to reach c7 and the digital subtraction angiography showed the subject guidewire tip was inside the distal access catheter.The physician then withdrew the distal access catheter and delivery catheter out and confirmed the tip of the guidewire was inside distal access catheter.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Event or Problem Description
It was reported that during the acute left middle cerebral artery occlusion procedure, the physician prepared to do in situ stenosis.Physician used a slim guidewire and multiple angiography catheter to bring delivery catheter to left internal carotid artery and exchanged with distal access catheter.Physician used the subject guidewire to bring the microcatheter to internal carotid artery c6.However, the subject guidewire could not be manipulated to advance.Digital subtraction angiography showed the tip of subject guidewire fractured in c6, so the physician withdrew the microcatheter but couldn't see the fractured tip.Physician then advanced the distal access catheter to reach c7 and the digital subtraction angiography showed the subject guidewire tip was inside the distal access catheter.The physician then withdrew the distal access catheter and delivery catheter out and confirmed the tip of the guidewire was inside distal access catheter.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
There are controls in the manufacturing process to ensure the product met specifications upon release.During visual/microscopic inspection, the guidewire was returned broken in two locations (187cm and 13cm).The guidewire was seen to have a slight kink 55cm from the proximal end.The proximal fragment was inspected, and the nitinol tubing was broken/fractured.The distal fragment was inspected, and the nitinol tubing was broken with the core wire exposed with an additional break roughly 1cm.The core wire was seen through the distal tip dome.Functional inspection was not applicable as the guidewire was broken/fractured.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 broken/fractured during use was confirmed during analysis.The reported guidewire difficult to advance could not be duplicated; however, the analysis results are 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.Additional information provided by the customer indicated that device was confirmed to be in good condition during preparation/prior to use on the patient, the device was set up as per dfu, continuous flush was set up and maintained throughout the clinical procedure.The patient¿s anatomy was moderately tortuous.During analysis the guidewire was returned broken in two locations (187cm and 13cm).There was a kink noted 55cm from the proximal end of the guidewire.It was not possible to do a functional test due to the break in the guidewire.An assignable cause of ¿procedural factors¿ will be assigned to the as analyzed and as reported ¿guidewire distal tip broken/fractured during use¿ the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.An assignable cause of ¿undeterminable¿ will be assigned to the as reported ¿guidewire difficult to advance¿, as a review and analysis of all available information fails to indicate an assignable cause or probable assignable cause.An assignable cause of 'handling damage' will be assigned to the as analyzed ¿guidewire kinked/bent¿ as the defect appears to be associated with handling of the product or portion of the product during preparation.

• Brand Name: SYNCHRO2-14 SOFT 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: 18380022
• Report Number: 3012931345-2023-00264
• Device Sequence Number: 7617114
• Product Code: DQX
• UDI-Device Identifier: 04546540688729
• UDI-Public: 04546540688729
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 02/16/2024

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: 10/12/2025
• Device Catalogue Number: M00326010
• Device Lot Number: 0000190561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/06/2023
• Supplement Date Received by Manufacturer: 01/26/2024
• Initial Report FDA Received Date: 12/21/2023
• Supplement Report FDA Received Date: 02/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2022
• 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: ANGIOGRAPHY CATHETER (UNKNOWN).; DAC DISTAL ACCESS CATHETER (STRYKER).; DELIVERY CATHETER (UNKNOWN).; GUIDEWIRE (UNKNOWN).; REBAR18 MICROCATHETER (MEDTRONIC).
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 50 KG
• Patient Race: Asian