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

Model Number 7267V

Device Problem Separation Problem (4043)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/04/2020

Event Type  Injury  

Manufacturer Narrative

There was no product returned for this complaint.No returned product evaluation could be completed.Manufacturing record review was completed and no related nonconformances were found.If the device returns for evaluation a follow-up report will be submitted.Cause could not be established.

Event Description

It was reported that the tip of the wire broke off in a patient during a difficult access of the popliteal vein.Procedure aborted due to the inability to gain vein access with neither the vsi product nor the competitive product.Hemostats were used to try to pull out the wire tip.No further complications were reported.

Manufacturer Narrative

No product was returned to vsi/teleflex for investigation.The account stated that resistance was met during advancement and withdrawal of the wire.It was also noted that the wire buckled many times during advancement, and it is unknown if there was a kink in the wire.The vessel was calcified and chronically occluded.Per ifu it states," 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".The most likely cause of the issue is use related during access.The type of damage and/or length of the tip separated cannot be determined without product evaluation.

Event Description

Additional information received to clarify the vessel was calcified and chronically occluded.There was resistance experienced while using the wire during advancement and withdrawal.

• Brand Name: MICRO-INTRODUCER KIT
• Type of Device: CATHTER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis, mn
• MDR Report Key: 10460323
• MDR Text Key: 204679167
• Report Number: 2134812-2020-00051
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 20841156102927
• UDI-Public: (01)20841156102927
• Combination Product (y/n): N
• PMA/PMN Number: K180913
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: 7267V
• Device Lot Number: 670810
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 104