MAUDE Adverse Event Report: VASCULAR SOLUTIONS LLC TRAPLINER 6F; CATHETER, PERCUTANEOUS

Catalog Number	5566
Medical Device Problem Codes	Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Udi number unavailable as dates are not available at present.Number will be sent with follow up report.
Event or Problem Description
It was reported that: " hypo tube push rod got detached from half pipe.Medical procedure was being performed was " percutaneous transfemoral coronary angioplasty" device removed entirely and treatment got delayed due to this defect." additional information: the issue occurred at the end of the procedure which was via the rca.The lesion was at the proximal end of the rca & distal rca.The procedure was completed but the device was damaged during extraction.The device was removed entirely, and treatment got delayed due to this defect.The patient was reported as fine wit reported harm or consequence.
Event or Problem Description
It was reported that: " hypo tube push rod got detached from half pipe.Medical procedure was being performed was " percutaneous transfemoral coronary angioplasty" device removed entirely and treatment got delayed due to this defect." additional information: the issue occurred at the end of the procedure which was via the rca.The lesion was at the proximal end of the rca & distal rca.The procedure was completed but the device was damaged during extraction.The device was removed entirely , and treatment got delayed due to this defect.The patient was reported as fine wit reported harm or consequence.
Additional Manufacturer Narrative
Qn# (b)(4).No return product evaluation could be completed as the device was not returned for investigation.A picture was share by the customer.Partial delamination of the pushrod from proximal end of the halfpipe was observed.The top-level assembly traveler 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.As per the additional information received, the vessel was rca.Lesion was at proximal and distal rca.No patient harm was noted.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.It is unknown if any damages were present at the halfpipe section causing the delamination or if any other ancillary devices were operated against resistance along with trapliner.Per customer, catheter was damaged during extraction.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 undeterminable.The der process will continue to monitor for any similar events.

• Brand Name: TRAPLINER 6F
• 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: 19738338
• Report Number: 2134812-2024-00030
• Device Sequence Number: 7720158
• Product Code: DQY
• UDI-Device Identifier: 10841156102128
• UDI-Public: (01)10841156102128(11)230914(17)250911(10)728059(21)
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K161901
• Number of Events Summarized: 1
• Summary Report (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): 06/17/2024

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 Expiration Date: 09/11/2025
• Device Catalogue Number: 5566
• Device Lot Number: 728059
• 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: 06/17/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/15/2024
• Supplement Report FDA Received Date: 08/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Age: 62 YR
• Patient Sex: Male