MAUDE Adverse Event Report: VASCULAR SOLUTIONS, LLC TWIN-PASS; DUEL ACCESS CATHETER,

Model Number 5200

Device Problem Separation Problem (4043)

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

Event Date 04/15/2019

Event Type  Injury  

Manufacturer Narrative

A returned product evaluation was completed and confirmed the complaint received.The catheter was severely damaged, and the distal 2.5cm of the rx lumen was separated.There was a longitudinal tear along the entire length of the rx lumen which most likely occurred outside of the body while the device was being pulled off the wire.There was also a 3cm longitudinal tear in the otw lumen starting at the distal port and moving proximal along the shaft.The catheter material was stretched at the separation point suggesting the catheter was withdrawn/pulled against resistance.The twin-pass ifu warns; "never advance or withdraw an intravascular device against resistance until the cause of the resistance is determined by fluoroscopy.Movement of the catheter against resistance may result in catheter damage or vessel injury." the distal marker band was pinched causing the catheter to appear deformed.This damage likely occurred while retrieving the tip from the patient.The separated distal tip and distal section of catheter were cross sectioned to confirm the unit was manufactured to specification.Operational context most likely caused or contributed to separation of the catheter tip.

Event Description

During a cto procedure the physician used a twin-pass to deliver a second wire in the rca crux.The tip of the twin-pass containing both platinum-iridium markers broke off in the guide during the removal of the catheter.When delivering the balloon, physician saw the tip of the twin-pass catheter with the markers on the wire being pushed by the balloon.Physician then delivered a balloon on the second wire and anchored it semi inflated to the guide tip then a larger balloon and then inflated and deflated it allowing it to wrap up the broken tip and used that to retrieve the broken tip on the wire.The tip with markers was retrieved in one piece with no other damage.The procedure was completed successfully.

• Brand Name: TWIN-PASS
• Type of Device: DUEL ACCESS 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: 8609389
• MDR Text Key: 145023546
• Report Number: 2134812-2019-00034
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: +M20652000Z
• UDI-Public: +M20652000Z
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083784
• 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: 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/09/2019
• Device Model Number: 5200
• Device Lot Number: 613035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/16/2019
• Initial Date FDA Received: 05/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2017
• 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 Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Weight: 101