MAUDE Adverse Event Report: VASCULAR SOLUTIONS LLC MI,4FST,40CM,SS/TUN,7ECO; CATHETER, PRODUCT CODE

Catalog Number 7262V

Device Problem Difficult to Advance (2920)

Patient Problem Insufficient Information (4580)

Event Date 01/26/2024

Event Type  Injury  

Event Description

It was reported that: the sheath portion of the micro introducer sheared off in the patient.Half was retrieved and the other half remains in the soft tissue.The portion of micro sheath (not wire) that broke was left in soft tissue and not retrievable.Patient condition was fine post procedure despite foreign body in tissue.No further treatment was performed.Dr (b)(6) decided to leave it there.Approx 4.5 cm left in soft tissue according to staff groin access was very difficult.Patient had bilateral bka and calcified vessels.The initial 18 gauge needles and.035 wires were bent on initial attempts.Radial access was also aborted due to difficulty.Stiff micro kit was utilized to overcome difficulty.Dilator and wire were removed for exchange to.035 wire.Wire wouldn't pass through micro sheath.Micro sheath broke at hub and middle during removal with resistance on pullback.

Manufacturer Narrative

(b)(4).

• Brand Name: MI,4FST,40CM,SS/TUN,7ECO
• Type of Device: CATHETER, PRODUCT CODE
• Manufacturer (Section D): VASCULAR SOLUTIONS LLC; minneapolis MN
• Manufacturer (Section G): VASCULAR SOLUTIONS LLC; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18739533
• MDR Text Key: 335761688
• Report Number: 2134812-2024-00005
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 7262V
• Device Lot Number: 73K2301084
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: NOT REPORTED
• Patient Weight: 90 KG