MAUDE Adverse Event Report: VASCULAR SOLUTIONS LLC TRAPLINER 8F; CATHETER, PERCUTANEOUS

Catalog Number	5568
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that: small marker at tip of catheter came off in a heavily calcified rca.Dr was able to inflate a balloon distal to it and drag the piece out and down into the sheath.He had to lose access, cut the sheath and remove the piece with the ballooned inflated along with the rest of the trapliner.No harm was caused to the patient.
Event or Problem Description
It was reported that: small marker at tip of catheter came off in a heavily calcified rca.Dr was able to inflate a balloon distal to it and drag the piece out and down into the sheath.He had to lose access, cut the sheath and remove the piece with the ballooned inflated along with the rest of the trapliner.No harm was caused to the patient.
Additional Manufacturer Narrative
(b)(4).One-unit of trapliner was returned to teleflex for evaluation.Blood particulates were noted on the unit.Balloon catheter was interlocked into the trapliner.The unit was removed.Severe tip and shaft damages were observed.Marker band was observed to be missing.The tip was cut open to expose the inner liner.The liner was observed to be prolapsed within the lumen.No liner material separation noted.The top-level assembly traveller (rt103622, lot 728911) 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, "small marker at tip of catheter came off in a heavily calcified rca.'' the damages are likely to have occurred during use in the procedure.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 based on the extent of damages noted, the trapliner was subjected to excessive resistance during its operation.Torque damages and lumen bulge could be noted along the length of the shaft.The marker band is tacked between the pebax and liner.It is unknown what clinical technique was employed in the case.As a result, the liner appears to be prolapsed within the lumen.A prolapsed liner would leave the marker band exposed.It is likely that that the markerband could have been pushed out during advancement of balloon catheter or other devices post the prolapsing of the liner.Physician was able to remove the piece with balloon inflation along with the trapliner.No harm was caused to the patient.A manufacturing record review was completed and no related nonconformances were found.Based on the information, the most likely root cause of the issue was operational context and/or unintended use error.The der process will continue to monitor for any similar events.
Additional Manufacturer Narrative
(b)(4).In section d provided the full udi # **udi related data quality updates only**.
Event or Problem Description
It was reported that: small marker at tip of catheter came off in a heavily calcified rca.Dr was able to inflate a balloon distal to it and drag the piece out and down into the sheath.He had to lose access, cut the sheath and remove the piece with the ballooned inflated along with the rest of the trapliner.No harm was caused to the patient.

• Brand Name: TRAPLINER 8F
• 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: marling heaton ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18354032
• Report Number: 2134812-2023-00059
• Device Sequence Number: 20526923
• Product Code: DQY
• UDI-Device Identifier: 10841156102142
• UDI-Public: (01)10841156102142(11)231020(17)251016(10)728911(21)
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/21/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: 5568
• Device Lot Number: 728911
• 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: 11/21/2023
• Supplement Date Received by Manufacturer: 11/21/2023; Not provided
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 01/17/2024; 08/20/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED; NOT REPORTED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female