MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO2-14 SOFT STRAIGHT 300CM; WIRE, GUIDE, CATHETER

Model Number	M00326310
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/27/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during the stroke treatment when physician delivered the balloon after crossing the tight stenosis, the tip of the subject guidewire was fractured inside the patient's anatomy.Attempts were made to retrieve the broken tip but the physician was unsuccessful and was left inside the patient.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during the stroke treatment when physician delivered the balloon after crossing the tight stenosis, the tip of the subject guidewire was fractured inside the patient's anatomy.Attempts were made to retrieve the broken tip but the physician was unsuccessful and was left inside the patient.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.The subject device is not available; therefore, functional testing as well as visual testing cannot be performed.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 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.It was reported that during the procedure, the tip of the subject guidewire got fractured and was left inside the patient's anatomy after attempts to retrieve the wire failed.The wire was stented down with non-stryker device that was already needed in the procedure for stenosis.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 of guidewire distal tip broken/fractured during use' and 'un-retrieved device fragments'.
Event or Problem Description
It was reported that during the stroke treatment when physician delivered the balloon after crossing the tight stenosis, the tip of the subject guidewire was fractured inside the patient's anatomy.Attempts were made to retrieve the broken tip but the physician was unsuccessful and was left inside the patient.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: SYNCHRO2-14 SOFT STRAIGHT 300CM
• 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: 13579319
• Report Number: 3012931345-2022-00032
• Device Sequence Number: 14907339
• Product Code: DQX
• UDI-Device Identifier: 04546540688743
• UDI-Public: 04546540688743
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 05/10/2022

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: 11/15/2023
• Device Model Number: M00326310
• Device Catalogue Number: M00326310
• Device Lot Number: 0000054642
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2022
• Supplement Date Received by Manufacturer: 04/13/2022
• Initial Report FDA Received Date: 02/22/2022
• Supplement Report FDA Received Date: 05/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2020
• 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: ACCLINO STENT (ACANDIS); CORONARY BALLOON (UNKNOWN)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown