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

Catalog Number	5567
Medical Device Problem Codes	Material Separation (1562); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "trapliner was being used during a case, when inserting further instruments the trapliner broke at the access point above the half pipe." the patient's current condition is reported as "unknown".Additional questions have been requested from the customer, however no additional information has been provided at this time.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Qn# (b)(4).One-unit of trapliner was returned to teleflex for evaluation.Blood particulates were noted.Unit was decontaminated was inspected.Partial delamination of the pushrod from the halfpipe collar section was noted.The collar section was damaged with wire wrap.The top-level assembly traveler (rt103621, lot 728422) 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 and the picture shared by the customer were reviewed.Partial delamination of the pushrod from the halfpipe collar section was noted.The collar section was damaged with wire wrap.Damages are likely to have occurred during use in the procedure along with other devices.The ifu 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 f luoroscopy.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.As per product evaluation, damages along the collar and halfpipe are indicative of concomitant device interaction and/or operation against resistance leading to the incurred damages observed.A manufacturing record review was completed for lot 728059 and no related nonconformances were found.Based on the information, the most likely root cause of the issue is operational context and/or unintended use error.The der process will continue to monitor for any similar events.
Event or Problem Description
It was reported "trapliner was being used during a case, when inserting further instruments the trapliner broke at the access point above the half pipe." the patient's current condition is reported as "unknown".Additional questions have been requested from the customer, however no additional information has been provided at this time.

• Brand Name: VSI TRAPLINER 7F
• Common Device Name: CATHETER, PERCUTANEOUS
• 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: 20035848
• Report Number: 2134812-2024-00037
• Device Sequence Number: 2998291
• Product Code: DQY
• UDI-Device Identifier: 10841156100551
• UDI-Public: (01)10841156100551(11)231004(17)251004(10)728422(21)
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K161901
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2024

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
• Device Expiration Date: 10/04/2025
• Device Catalogue Number: 5567
• Device Lot Number: 728422
• 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: 07/26/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown