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 Codes	Hematoma (1884); Perforation (2001)
Date of Event	01/13/2021
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 successful pci to a non-tortuous, moderately calcific cto of the proximal rca on cto pci study subject (b)(6), subject suffered an ellis grade 1 vessel perforation to an epicardial collateral from the cfx which resulted in a residual hematoma.Many devices, both study and non-study, were used in the procedure.Study devices included a turnpike microcatheter, turnpike lp microcatheter and a raider guidewire.It is unknown which device caused the perforation but felt to be caused by a non-study device.Perforation treated with coil embolization (0.014" coils x 2) with resolution, hematoma treated with cutting balloon with moderate success of decompression and small residual hematoma.Tee performed prior to discharge showed no pericardial effusion.Discharged home next day with no further sequelae.Associated to mdrs: 2134812-2021-00033 turnpike smooth.2134812-2021-00034 turnpike lp.
Additional Manufacturer Narrative
There was no product returned for this complaint.No returned product evaluation could be completed.Lot 680191 was reviewed.There are no nonconformances related to this lot therefore supporting the device met material, assembly and performance specifications.Case details was reviewed.A patient underwent a pci procedure.Vessel was moderately calcific and non-tortuous.The patient endured an ellis grade 1 perforation to an epicardial collateral from the cfx which resulted in residual hematoma.A raider (study device) was one of the devices used in the procedure.Per ifu, a vessel perforation and hematoma are identified as potential adverse effects that may be associated with the use of the raider guidewires.No product was returned to vsi/teleflex for investigation.It is unknown if any damages were present on the raider that could have contributed to the event.Multiple ancillary devices were also used in the case.The event details states that it is unknown which device caused the perforation but likely a non-study device.The perforation was treated with coil embolization (0.014" coils x 2).Hematoma treated with cutting balloon with moderate success of decompression.Tee performed prior to discharge showed no pericardial effusion.Patient discharged home next day with no further sequelae.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: 11668191
• Report Number: 2134812-2021-00032
• Device Sequence Number: 2936400
• Product Code: DQX
• UDI-Device Identifier: 10841156101275
• UDI-Public: (01)10841156101275
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: 09/04/2022
• Device Model Number: 7448
• Device Catalogue Number: 7448
• Device Lot Number: 680191
• 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: Other; Required Intervention
• Patient Age: 70 YR