MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO-14 STRAIGHT 300-45CM; WIRE, GUIDE, CATHETER

Model Number	M00313320
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer disposed of product.
Event or Problem Description
It was reported that during the procedure the guidewire (subject device) was broken during at the external artery branch.A snare device was used to remove the broken pieces of the guidewire.The patients medical condition was good.There were no clinical consequences to the patient.
Additional Manufacturer Narrative
The subject device is not available; therefore, visual and functional testing as well as physical analysis cannot be performed.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.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 and there was no friction/resistance encountered during the procedure.The broken synchro wire was noted when they placed the wire in the external carotid artery and the broken pieces of the device were removed with a snare.The patient¿s anatomy was medium tortuous.There were no patient consequences reported due to this event.Additional information also indicates continuous flush was not maintained for the duration of the procedure.As per dfu maintaining continuous flush throughout the procedure is a critical requirement as lack of it can lead to friction or other related difficulties.It is probable in the case of this complaint the lack of flush would have contributed to the device becoming damaged as additional manipulation would be required to advance the guidewire.An assignable cause of ¿user error¿ will be assigned to reported event, as the investigation confirmed that there was an act or omission of an act that resulted in a different medical device response than intended by the manufacturer and/or expected by the user.
Event or Problem Description
It was reported that during the procedure the guidewire (subject device) was broken during at the external artery branch.A snare device was used to remove the broken pieces of the guidewire.The patients medical condition was good.There were no clinical consequences to the patient.

• Brand Name: SYNCHRO-14 STRAIGHT 300-45CM
• 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: 11083565
• Report Number: 3012931345-2020-00229
• Device Sequence Number: 3754352
• Product Code: DQX
• UDI-Device Identifier: 07613252186953
• UDI-Public: 07613252186953
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K032146
• 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): 01/20/2021

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 Model Number: M00313320
• Device Catalogue Number: M00313320
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/30/2020
• Supplement Date Received by Manufacturer: 01/06/2021
• Initial Report FDA Received Date: 12/28/2020
• Supplement Report FDA Received Date: 01/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention