MAUDE Adverse Event Report: VASCULAR SOLUTIONS, LLC R350 GUIDEWIRE

Model Number	7390
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	09/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing record was reviewed, there were no nonconformance related to this lot, therefore, supporting the device met material, assembly and performance specifications.A follow-up report will be issued after the investigation is complete.
Event or Problem Description
As reported: during a study case, following retrograde cto pci of the rca, patient developed a small intraseptal hematoma which was noted on angiography but not via echocardiogram.Treated with two intracoronary coils with decrease flow noted.Patient was observed in the cath lab for an additional 20 min.Post-coil deployment with repeat angiography showing no further enlargement of the hematoma.Site states that the cause of the hematoma was due to the r350 externalization guidewire (study device) being removed from septal too quickly.
Additional Manufacturer Narrative
There was no product returned for this complaint.No returned product evaluation could be completed.The patient condition is fine.No other events reported.A manufacturing record review was completed no related non-conformances were noted.Case details were reviewed.Patient underwent cto pci procedure of the rca vessel.An r350 guidewire was used in the case.Patient developed a small intra septal hematoma.Per ifu, it identifies hematoma as potential adverse effects that may be associated with the r350 guidewire.No device was returned to vsi/teleflex for investigation.It is unknown if any damage was present on the guidewire during use that could have caused the event.Account stated that cause of the hematoma was due to the r350 guidewire being removed from the septal too quickly.No fluoroscopy images or angiograms were shared by the account.The issue was treated with intracoronary coils (i.E.Coil embolization procedure with 2.0 x 6 and 4.0 x6 coils).Decrease in flow was observed.Angiography was performed post coil deployment.No further enlargement of hematoma was observed.

• Brand Name: R350 GUIDEWIRE
• Common Device Name: GUIDEWIRE
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 11424002
• Report Number: 2134812-2021-00012
• Device Sequence Number: 3882326
• Product Code: DQX
• UDI-Device Identifier: 30841156101170
• UDI-Public: (01)30841156101170
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K151234
• 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): 02/04/2021

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: 02/19/2022
• Device Model Number: 7390
• Device Lot Number: 667947
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/04/2021
• Supplement Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 03/05/2021
• Supplement Report FDA Received Date: 07/22/2021
• 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: 76 YR
• Patient Weight: 70