MAUDE Adverse Event Report: VASCULAR SOLUTIONS LLC TRAPLINER 7F; CATHETER

Catalog Number	5567
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "the balloon section bent & separated while loading into the guide catheter.Trap liner buckled & separation occurred after minimal force was applied to advance.Trap liner was removed & a second trap liner was inserted & used." additional information: the issue occurred prior to use on the patient.The trapliner broke mid balloon.The trapliner was removed from guide cath --new one opened and used without issue.There was no effect to the patient.
Event or Problem Description
It was reported that: "the balloon section bent & separated while loading into the guide catheter.Trap liner buckled & separation occurred after minimal force was applied to advance.Trap liner was removed & a second trap liner was inserted & used." additional information: the issue occurred prior to use on the patient.The trapliner broke mid balloon.The trapliner was removed from guide cath --new one opened and used without issue.There was no effect to the patient.
Additional Manufacturer Narrative
Qn# (b)(4).One-unit of trapliner was returned for evaluation.Blood particulates were noted on the unit.The unit was decontaminated and inspected.Separation of the shaft was noted at the balloon section.The top-level assembly traveler (rt102870, lot 723964) was reviewed.There are no dda's, nce's or any other nonconformances related to this lot therefore supporting the device met material, assembly, and performance specifications.Case details were reviewed.Customer stated, "balloon section bent & separated while loading into the guide catheter.Trap liner buckled & separation occurred after minimal force was applied to advance." as per the additional information received, trapliner did not enter the vasculature of the patient.It broke in the guide catheter.No patient harm or injury noted.It is unclear how the trapliner got buckled.Per product evaluation, tension at the separated junction was noted.The 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.A manufacturing record review was completed and no related nonconformances were found.Based on the information, the most likely root cause of the issue is operational context.The der process will continue to monitor for any similar events.

• Brand Name: TRAPLINER 7F
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS LLC; minneapolis MN
• Manufacturer (Section G): VASCULAR SOLUTIONS LLC; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18967966
• Report Number: 2134812-2024-00011
• Device Sequence Number: 12464329
• Product Code: DQY
• UDI-Device Identifier: 10841156100551
• UDI-Public: 10841156100551
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2024

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 Catalogue Number: 5567
• Device Lot Number: 723964
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2024
• Supplement Date Received by Manufacturer: 02/26/2024
• Initial Report FDA Received Date: 03/25/2024
• Supplement Report FDA Received Date: 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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