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U.S. Department of Health and Human Services

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

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VASCULAR SOLUTIONS, LLC TWIN-PASS; DUEL ACCESS CATHETER, Back to Search Results
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moving proximal along the shaft.The catheter material was stretched at the separation point suggesting the catheter was withdrawn/pulled against resistance.The twin-pass ifu warns; "never advance or withdraw an intravascular device against resistance until the cause of the resistance is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.
 
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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 Key8609389
MDR Text Key145023546
Report Number2134812-2019-00034
Device Sequence Number1
Product Code DQY
UDI-Device Identifier+M20652000Z
UDI-Public+M20652000Z
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K083784
Number of Events Reported1
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 Date11/09/2019
Device Model Number5200
Device Lot Number613035
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/22/2019
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/16/2019
Initial Date FDA Received05/14/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/21/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age78 YR
Patient Weight101
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