MAUDE Adverse Event Report: VASCULAR SOLUTIONS, LLC TRAPLINER; CATHETER

Model Number	5567
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: catheter came apart during a case - balloon failed to inflate.
Additional Manufacturer Narrative
Trapliner was returned for evaluation.Blood particulates were noted on the lumen and within the balloon.Weld joint separation was observed.Tip section was crimped.Minor kink was noted on the push rod.The balloon was fatigued.Pushrod, weld joint to tip, o.D, id, collar to tip, were measured within specification.Balloon cannot be functionally tested due to the damages observed.Per ifu it states the following warning and precaution - never advance, withdraw, or rotate an intravascular device against resistance until the cause of the resistance is determined by fluoroscopy.Movement of the catheter against resistance may result in separation of the catheter or guidewire tip, other device damage, or vessel injury - exercise care in handling the catheter during a procedure to reduce the possibility of accidental breakage or kinking.Do not apply torque to the catheter during delivery, as catheter damage may result.Additional information was requested from the account.A response was received.Vessel was calcified and not tortuous.Balloon was prepped prior to use without any issue.It is unknown what pressure was used to inflate it.Balloon was inflated to trap the wire however, it did not work.Thetrapliner was taken out with only the shaft (likely the pushrod) being retrieved.The account inserted a balloon inside the catheter (likely the guide catheter), inflated and retrieved the remaining part of the trapliner from the vessel.It is likely that the weld joint of the hypotube could have broken (partially or completely) during or prior to inflation leading to non-functionality of the balloon.This subsequently could have led to wire unable to be trapped.It is unknown if another trapliner or any other unit was used to complete the procedure.Patient condition is fine.

• Brand Name: TRAPLINER
• Common Device Name: 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 ; 7636564300
• MDR Report Key: 12392266
• Report Number: 2134812-2021-00062
• Device Sequence Number: 17324527
• Product Code: DQY
• UDI-Device Identifier: 20841156102132
• UDI-Public: 20841156102132
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K161901
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/15/2023
• Device Model Number: 5567
• Device Lot Number: 705669
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2021
• Supplement Date Received by Manufacturer: 08/06/2021
• Initial Report FDA Received Date: 08/31/2021
• Supplement Report FDA Received Date: 11/26/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/03/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown