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

Model Number	M00326420
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is not available to manufacturer.
Event or Problem Description
It was reported that during the stroke procedure, a guidewire (subject device) was advanced to m2 without any difficulties.After accessing m2 section, a part of the distal tip of the subject guidewire sheared off.A catheter which was already in use was used with suction to retrieve fractured tip of the subject guidewire.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 stroke procedure, a guidewire (subject device) was advanced to m2 without any difficulties.After accessing m2 section, a part of the distal tip of the subject guidewire sheared off.A catheter which was already in use was used with suction to retrieve fractured tip of the subject guidewire.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
File attachment: attached fda letter as a file.H3 device evaluated by mfg ¿updated.H3 summary attached - updated.D9 product available to stryker ¿ updated.D9 returned to manufacturer on ¿updated.Based on the results of the dhr review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.During visual inspection, the guidewire was returned in 2 segments.The nitinol tubing was broken from the distal end with the core wire exposed and broken.The platinum wire was also exposed and broken.Rough surfaces were evident around the broken nitinol tubing, core wire and platinum.The nitinol tubing was also broken from the proximal end and the core wire exposed, twisted and broken.The nitinol tubing proximal bond and distal bond joints were in place.The corewire distal end was observed through the distal tip dome.The guidewire distal section and hydrophilic coating was examined along its length with wet fingers and the coating was present on the guidewire.The guidewire ptfe coating was examined under magnification and no anomaly was noted.A functional test was not required as the defect was visually confirmed.The event was confirmed based on the damage noted to the returned device.The device failed to meet specification when returned for analysis.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 there was no damage noted to the packaging prior to preparation of the device, there were no anomalies noted to the device during initial inspection and preparation and the device was prepared as per the dfu.The dispenser hoop was flushed before removing the guidewire and there was no resistance encountered removing the guidewire from the dispenser hoop.The guidewire tip was not shaped, continuous flush was maintained for the duration of the procedure, there was no friction/resistance encountered during the procedure and there were no other difficulties encountered during the usage of the device that could have contributed to the issue.The tortuosity of the patient¿s anatomy is unknown.The model of microcatheter and the inner diameter of the microcatheter used in the procedure is unknown.The other associated devices used in conjunction with device in the reported event are unknown.The issue was noted during the procedure while accessing m2.It is unknown how the break/spit occurred during the case.A non-stryker catheter was used with suction to retrieve the broken/fractures guidewire tip from the patient¿s anatomy and it was was successfully retrieved.The non-stryker catheter, that was used with suction to retrieve tip, was already prepared for use in the procedure from the beginning as this was a stroke case.There were no unanticipated medical procedures/treatments/therapy administered in relation to the alleged event or product malfunction.The procedure was successfully completed with no patient issues.An assignable cause of procedural factors will be assigned to the reported and analyzed guidewire distal tip broken/fractured during use in addition to the analyzed guidewire distal tip stretched as 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.

• Brand Name: SYNCHRO2-14 STANDARD PRE-SHAPED 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
• MDR Report Key: 11795729
• Report Number: 3012931345-2021-00072
• Device Sequence Number: 3660727
• Product Code: DQX
• UDI-Device Identifier: 04546540688774
• UDI-Public: 04546540688774
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 09/10/2021

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: 02/22/2024
• Device Model Number: M00326420
• Device Catalogue Number: M00326420
• Device Lot Number: 0000059221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2021
• Initial Date Received by Manufacturer: 04/14/2021
• Supplement Date Received by Manufacturer: 08/19/2021
• Initial Report FDA Received Date: 05/10/2021
• Supplement Report FDA Received Date: 09/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CATHETER (PENUMBRA); UNKNOWN ASPIRATION PUMP