MAUDE Adverse Event Report: VASCULAR SOLUTIONS LLC MICRO-INTRODUCER KIT; CATHETER

Model Number	7256V
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/01/2020
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
Received via medwatch 4400150000-2020-8024, dated (b)(6) 2020; 20200929144041740.Reported as: post guided access to the left common femoral artery abdominal arteriogram.Right superficial femoral artery, and popliteal artery angioplasty.Tip broke off dilator.
Additional Manufacturer Narrative
One-unit of mik was returned to vsi/teleflex for evaluation.A manufacturing record review was completed and no related nonconformances were found.Blood particulates were found on the dilator hub.Only the dilator was returned.The tip portion separated from the dilator.Stretching of the polymer was observed.No other damage was noted on the dilator.The damages are likely due to the dilator being pulled against resistance.Per ifu it state, the following warning" never advance or withdraw an intravascular device against resistance until the cause of the resistance is determined by fluoroscopy.Movement of the guidewire against resistance may result in separation of the guidewire tip, damage to the guidewire, or vessel perforation".Additional information on the procedure was requested from the account.No response was received.Based on the product evaluation, the most likely root cause of the issue is operational context.

• Brand Name: MICRO-INTRODUCER KIT
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 10731822
• Report Number: 2134812-2020-00085
• Device Sequence Number: 19114575
• Product Code: DYB
• UDI-Device Identifier: 10841156102906
• UDI-Public: (01)10841156102906
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K180913
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2020

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: 01/31/2023
• Device Model Number: 7256V
• Device Catalogue Number: 7265V
• Device Lot Number: 666802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Initial Date Received by Manufacturer: 09/29/2020
• Supplement Date Received by Manufacturer: 09/29/2020
• Initial Report FDA Received Date: 10/24/2020
• Supplement Report FDA Received Date: 01/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 106