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

Model Number	5571
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2020
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: started to load guideliner v3 onto wire when "hypo tube" caught on valve.Physician noticed that with each push, the back dark blue plastic piece that extends from "tube" onto wire, started to come off wire.Device never made it into body, or guide, so no intervention needed to retrieve anything.No harm due to device issue.
Additional Manufacturer Narrative
Guideliner was returned to vsi for evaluation.The guideliner pushrod was separating from the proximal half-pipe.The manufacturing records were reviewed, and there were no nonconformances related to this lot, therefore, supporting the device met material, assembly, and performance specifications.The event description states the guideliner broke apart.The underside of the guideliner had the push rod exposed through the pebax material.No other damage was noted.An internal corrective action was initiated to further investigate.Per the investigation, no probable cause was determined, no root cause could be established.

• Brand Name: GUIDELINER V3
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 10686362
• Report Number: 2134812-2020-00071
• Device Sequence Number: 16882757
• Product Code: DQY
• UDI-Device Identifier: 10841156100605
• UDI-Public: (01)10841156100605
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• 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): 09/17/2020

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 Model Number: 5571
• Device Catalogue Number: 5571
• Device Lot Number: 669953
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2020
• Initial Date Received by Manufacturer: 09/17/2020
• Supplement Date Received by Manufacturer: 09/17/2020
• Initial Report FDA Received Date: 10/15/2020
• Supplement Report FDA Received Date: 08/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1