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	Peeled/Delaminated (1454)
Health Effect - Clinical Codes	Thrombosis/Thrombus (4440); Insufficient Information (4580)
Date of Event	06/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during procedure the coating came off through the introducer, dr.Whipped off and continued using it.Therefore, this might caused vessel thrombosis.Patient currently status is unknown.
Event or Problem Description
It was reported that during procedure the coating came off through the introducer, dr.Whipped off and continued using it.Therefore, this might caused vessel thrombosis.Patient currently status is unknown.
Additional Manufacturer Narrative
There are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product 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.Additional information provided by the customer indicated that no anomalies were noted to the device during initial inspection and preparation, the device was prepared as per the dfu, the dispenser hoop was flushed before removing the guidewire, no resistance was encountered when removing the guidewire from the dispenser hoop, the introducer sheath was used with the guidewire during the insertion process, continuous flush was maintained for the duration of the procedure, there were no allegations against the microcatheter used with the wire, and the coating was noticed outside of the patient.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause and the device was not returned, an assignable cause of undeterminable was assigned to this complaint.
Additional Manufacturer Narrative
Section b1 adverse event/product problem - corrected - no adverse event.B2 outcomes attributed to ae -corrected - no other serious (important medical events).B5 executive summary - updated.Section h1 - corrected from serious injury to malfunction.F10 / h6 clinical signs code grid - health effect - clinical code - updated.There are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product 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.Additional information provided by the customer indicated that no anomalies were noted to the device during initial inspection and preparation, the device was prepared as per the dfu, the dispenser hoop was flushed before removing the guidewire, no resistance was encountered when removing the guidewire from the dispenser hoop, the introducer sheath was used with the guidewire during the insertion process, continuous flush was maintained for the duration of the procedure, there were no allegations against the microcatheter used with the wire, and the coating was noticed outside of the patient.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause and the device was not returned, an assignable cause of undeterminable was assigned to the reported event 'guidewire ptfe coating peeling'.
Event or Problem Description
It was reported that during procedure the coating came off through the introducer, dr.Whipped off and continued using it.Therefore, this might caused vessel thrombosis.Patient currently status is unknown.Update: it was reported that during procedure the coating came off through the introducer, dr.Whipped off and continued using it.No additional information available.

• 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
• 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: 12128992
• Report Number: 3012931345-2021-00107
• Device Sequence Number: 11635460
• Product Code: DQX
• UDI-Device Identifier: 04546540688774
• UDI-Public: 04546540688774
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/15/2024

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 Expiration Date: 04/25/2024
• Device Model Number: M00326420
• Device Catalogue Number: M00326420
• Device Lot Number: 0000063007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/16/2021
• Supplement Date Received by Manufacturer: 11/29/2021; 05/10/2024
• Initial Report FDA Received Date: 07/07/2021
• Supplement Report FDA Received Date: 12/09/2021; 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown