MAUDE Adverse Event Report: VASCULAR SOLUTIONS, LLC RAIDER GUIDEWIRE

Model Number	7448
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	12/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing records will be reviewed.A follow-up report will be issued after the investigation is complete.
Event or Problem Description
As reported: during a cto pci index procedure for the cto-pci study of a long, severely calcific non-tortuous lesion located in the mid-lcx, the subject suffered an ellis ii perforation of the target vessel with a raider guidewire (study device).There was free flowing pericardial effusion, circumferential but largest anteriorly with hematoma formation post prolonged balloon inflation.Subject was hypertensive during the event.Treated with prolonged balloon inflation with residual dissection noted.Resolved without further sequelae.No adverse events were reported at study 30-day follow-up visit.
Additional Manufacturer Narrative
There was no product returned for this complaint.No returned product evaluation could be completed.Dhr review was requested.No nces or deviations were observed.All processes were followed correctly.Case details were reviewed.Patient underwent a cto pci procedure.The vessel was mid lcx with severe calcification and no tortuosity.A raider guidewire was used in the procedure.Patient endured an ellis ii perforation of the target vessel.Also, there was free flowing pericardial effusion, circumferential but largest anteriorly with hematoma formation post prolonged balloon inflation.Patient was hypertensive during the event.Balloon inflation was employed for treatment with residual dissection noted.Per ifu: vessel perforation, dissection and hematoma are identified as potential adverse effects that may be associated with the raider guidewire.No product was returned to vsi/teleflex for investigation.It is unknown if any damages were present with the raider device that could have contributed to the event.All issues were resolved without any sequelae.No adverse events were reported at study 30-day follow-up visit.Based on the information, the most likely root cause of the issue is undeterminable.

• Brand Name: RAIDER GUIDEWIRE
• Common Device Name: GUIDEWIRE
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 11668175
• Report Number: 2134812-2021-00031
• Device Sequence Number: 19567193
• Product Code: DQX
• UDI-Device Identifier: 30841156101279
• UDI-Public: (01)30841156101279
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K173532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2021

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: 09/23/2022
• Device Model Number: 7448
• Device Lot Number: 701054
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/25/2021
• Supplement Date Received by Manufacturer: 03/25/2021
• Initial Report FDA Received Date: 04/14/2021
• Supplement Report FDA Received Date: 07/20/2021
• 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
• Patient Age: 73 YR
• Patient Weight: 91