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

Model Number 7267V

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/19/2019

Event Type  malfunction  

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 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
• Type of Device: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer (Section G): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer Contact: mary haufek ; 6464 sycamore court north; minneapolis, MN 55369 ; 7636564230
• MDR Report Key: 9167737
• MDR Text Key: 207938582
• Report Number: 2134812-2019-00069
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10841156102920
• UDI-Public: (01)10841156102920
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180913
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Weight: 86