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

Model Number	7266V
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Date of Event	08/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A returned product evaluation was unable to be completed as no devices were returned.A manufacturing record review was completed and no related non-conformances were found, therefore supporting the device met material, assembly and performance specifications.Based on the event details, it likely became caught on the point of the needle causing the separation of the tip.The ifu warns; "do not withdraw guidewires through metal needles; guidewires may shear or unravel.".
Event or Problem Description
Received sus voluntary report mw5089562 on 19sep2019 physician attempted access through a highly calcified vessel in the common femoral.Difficulty experienced during access.Nitinol wire was advanced through the needle, then retrieved.Upon retrieval, a portion of the wire tip was sheared off.

• 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: 9167618
• Report Number: 2134812-2019-00068
• Device Sequence Number: 11430266
• Product Code: DYB
• UDI-Device Identifier: 10841156102913
• UDI-Public: (01)10841156102913
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K180913
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: 7266V
• Device Catalogue Number: 7266V
• Device Lot Number: 652623
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/19/2019
• Initial Report FDA Received Date: 10/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1