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).

Manufacturer Narrative

(b)(4).No returned product evaluation could be completed as no product returned for this complaint.A picture was provided by the customer.The hub and sheath were observed to be separated.As per the information provided by the customer, 4.5 cm of sheath was left in the tissue.A dhr review was completed for 73k2301084, and no issues or non-conformities were noted.As per the additional information received, the right femoral artery was very calcified.The patient had bka (below knee amputation) and difficult groin access.During access with a 18g needle, the needle was observed to be bent.No pictures of the needle were provided by the customer.Physician tried the micro introducer kit (mik).The mik broke at the hub and middle due to resistance on pullback.Patient condition was fine despite the sheath present in the tissue.The broken sheath could not be retrieved.Physician decided to leave it in the tissue.Da mages were likely to have occurred during use when operated against a calcified difficult vessel.The ifu states 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.Based on the information, the most likely root cause of the issue is operational context and/or unintended use error.The der process will continue to monitor for any similar events.

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 garnett 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.

• 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

• 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
• Initial Date Manufacturer Received: 01/26/2024
• Initial Date FDA Received: 02/20/2024
• Supplement Dates Manufacturer Received: 01/26/2024
• Supplement Dates FDA Received: 03/21/2024
• 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; NOT REPORTED
• Patient Weight: 90 KG