MAUDE Adverse Event Report: VASCULAR SOLUTIONS LLC GUIDELINER V3; CATHETER

Model Number	5569
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2020
Type of Reportable Event	Malfunction
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 pci plus stenting, a piece of the guideliner v3 broke off, however, found and saved.Broken part is in a little container.Device professional alleges the device did not contribute to the event.No medical intervention reported.Multiple attempts have been made to receive additional information, however, no response has been received at this time.Ported: during a pci plus stenting, a piece of the guideliner v3 broke off, however, found and saved.Broken part is in a little container.Device professional alleges the device did not contribute to the event.No medical intervention reported.Multiple attempts have been made to receive additional information, however, no response has been received at this time.
Additional Manufacturer Narrative
Product was returned for investigation.A manufacturing record review was completed and no related non-conformances were found.A returned product evaluation was completed.There was damage found along the shaft of the guideliner.The collar section showed signs of wire wrap.White flakes were received with the device.The white material particulate found and collected by the physician on the device was confirmed to be the same material as the pad print ink through an infrared spectroscopy analysis (ftir) of the unknown sample and a control sample of the ink.Through the analysis of the spectra, it was shown that the materials are highly likely to be the same.The guideliner shaft was intact and no section of the lumen was separated.The most likely root cause for the failure is manufacturing related.An internal non-conformance was issued to address this issue.

• Brand Name: GUIDELINER V3
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 10684817
• Report Number: 2134812-2020-00069
• Device Sequence Number: 2954937
• Product Code: DQY
• UDI-Device Identifier: 10841156100575
• UDI-Public: (01)10841156100575
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K172090
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2020

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 Expiration Date: 03/06/2022
• Device Model Number: 5569
• Device Catalogue Number: 5569
• Device Lot Number: 669255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Initial Date Received by Manufacturer: 09/16/2020
• Supplement Date Received by Manufacturer: 09/16/2020
• Initial Report FDA Received Date: 10/15/2020
• Supplement Report FDA Received Date: 03/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1