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

Model Number	5568
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: a piece of trapliner broke off when tech was prepping it.Not used on a patient.No additional information recieved.
Additional Manufacturer Narrative
Qn#: (b)(4).
Additional Manufacturer Narrative
Qn#(b)(4).One-unit of trapliner was returned to vsi/teleflex for evaluation.Blood particulates were noted within the lumen.Unit was decontaminated and inspected.Weld joint separation was confirmed.Minor lumen depression at the proximal end of the halfpipe was noted.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.Customer stated" piece of trapline broke off when tech was prepping it".Damages are likely to have occurred during use and handling.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.No other information was provided aside from the trapliner being snapped during preparation.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 and/or unintended use error.
Event or Problem Description
It was reported that: a piece of trapliner broke off when tech was prepping it.Not used on a patient.No additional information recieved.

• Brand Name: TRAPLINER
• 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: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17601453
• Report Number: 2134812-2023-00040
• Device Sequence Number: 6307597
• Product Code: DQY
• UDI-Device Identifier: 10841156100568
• UDI-Public: 10841156100568
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2023

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: 05/01/2025
• Device Model Number: 5568
• Device Catalogue Number: 5568
• Device Lot Number: 724775
• 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: 07/27/2023
• Supplement Date Received by Manufacturer: 07/27/2023
• Initial Report FDA Received Date: 08/23/2023
• Supplement Report FDA Received Date: 09/29/2023
• 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
• Patient Sex: Unknown