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

Model Number	7267V
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The outer layer of material (blue) was separated.The separation point was stretched suggesting the dilator was pulled against resistance.The sheath was also shown in the picture, but it was undeterminable if damage was present that could have led to the separation.Without the device returning further investigation could not be completed.
Event or Problem Description
Lost part of the dilator in patient during procedure.Not noticed until scrub tech noticed part of the dilator was missing when she noticed it on the back table.They fluoro'd patient but couldn't see the dilator.Embolized and still in the body.Patient was treated for scheduled procedure through existing access.Later ct scan revealed it is still in the common femoral artery and doctor is determining whether to go back in after it or leave it.After multiple attempts, no further information received, however, images were received to support investigation.

• 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: 9167737
• Report Number: 2134812-2019-00069
• Device Sequence Number: 13994453
• Product Code: DYB
• UDI-Device Identifier: 10841156102920
• UDI-Public: (01)10841156102920
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/20/2019

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: 06/30/2022
• Device Model Number: 7267V
• Device Catalogue Number: 7267V
• Device Lot Number: 654272
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/20/2019
• 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
• Patient Age: 81 YR
• Patient Weight: 86