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	12/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow-up report will be issued after the investigation is complete.
Event or Problem Description
As reported: trapliner was inserted.Upon inflation of the balloon blood coming back into inflation syringe.Providers assumed balloon was ruptured.After it was removed it was noted that the hypo-tube separated at the tip of the catheter.Upon inspection of the device, it appears the hypo-tube was damaged either from manufacturer, or upon removal of packaging, or during insertion through guide catheter.It is unknown when it was damaged.No patient harm.Successful case results.
Additional Manufacturer Narrative
One-unit of trapliner was returned for evaluation.Blood particulates were noted on the unit.The balloon was fatigued with blood particulates within the balloon.No damages noted on the rx lumen.Weld joint separation was confirmed.Small layer of pebax at the proximal part of the half was damaged.The device history records were reviewed.There are no nonconformances related to this lot therefore supporting the device met material, assembly, and performance specifications.Case details were reviewed.A patient underwent a pci procedure.A trapliner was used.Upon inflation of the balloon, blood was observed to flow back into the inflation syringe.Damages are likely to have occurred during use in the procedure.Per ifu, states the following precaution: - 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 lad.Trapliner was prepped without any issues.Trapliner broke at the flex point and was removed.It is likely that the catheter weld joint was damaged during use leading to partial damage at the hypo tube causing blood to flow back in the balloon and back into the syringe.The complete separation could have then occurred when removed from the body.Account stated that the trapliner was intact when removed in its entirety and then separated.Procedure was completed with another trapping balloon unit.No patient harm noted, and procedure outcome was successful.Based on the information, the most likely root cause of the issue is operation context and/or unintended use error.

• 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: 13175137
• Report Number: 2134812-2022-00003
• Device Sequence Number: 4517994
• Product Code: DQY
• UDI-Device Identifier: 10841156102135
• UDI-Public: 10841156102135
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2021

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: 10/20/2023
• Device Model Number: 5567
• Device Catalogue Number: 5567
• Device Lot Number: 713718
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2021
• Supplement Date Received by Manufacturer: 12/08/2021
• Initial Report FDA Received Date: 01/06/2022
• Supplement Report FDA Received Date: 03/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2021
• 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
• Outcome Attributed to Adverse Event: Congenital Anomaly
• Patient Sex: Unknown