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

Model Number	07613327459647
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Perforation of Vessels (2135)
Date of Event	08/12/2020
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 procedure, there was perforation of a small vessel distal to the lesion which led to bleeding.Perforation was treated using codman glue and bleeding contained.The procedure was completed successfully.
Additional Manufacturer Narrative
D4: expiration date: added.H4: manufacturing date: added.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.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.It was reported that during initial access with the guidewire, there was vessel perforation distal to the lesion that led to bleeding.The bleeding was treated using codman glue and the bleeding stopped after intervention.Additional information provided by the customer indicated that no anomalies were noted to the device after removal from the packaging or prior to preparation.Based on the information provided, the causal relationship between the subject device and the reported adverse events is unknown.The reported vessel perforation and hemorrhage, blood loss with sequelae are known and anticipated complications to these types of procedures and patient condition and are listed as such in the device directions for use.Therefore, an assignable cause of anticipated procedural complication will be assigned to this event.
Event or Problem Description
It was reported that during the procedure, there was perforation of a small vessel distal to the lesion which led to bleeding.Perforation was treated using codman glue and bleeding contained.The procedure was completed successfully.

• Brand Name: SYNCHRO2-14 SUPPORT 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
• MDR Report Key: 10494992
• Report Number: 3012931345-2020-00131
• Device Sequence Number: 11564036
• Product Code: DQX
• UDI-Device Identifier: 07613327459647
• UDI-Public: 07613327459647
• Combination Product (Y/N): N
• Initial Reporter State: DC
• 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): 10/28/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/22/2022
• Device Model Number: 07613327459647
• Device Catalogue Number: S2SPS14300
• Device Lot Number: 0000028763
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/12/2020
• Supplement Date Received by Manufacturer: 10/06/2020
• Initial Report FDA Received Date: 09/04/2020
• Supplement Report FDA Received Date: 10/28/2020
• 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: SL-10 MICRO CATHETER (STRYKER).; WINGSPAN STENT SYSTEM(STRYKER).; SL-10 MICRO CATHETER (STRYKER); WINGSPAN STENT SYSTEM(STRYKER)
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 50 YR