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

Model Number	5566
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One trapliner was returned for evaluation.A manufacturing record review was completed and no related nonconformances were found supporting the device met material, assembly and performance specifications.A returned product evaluation was completed.The catheter pushrod and distal shaft were separated at the hypotube ribbon weld.The most likely root cause for the separation is operational context and unintended user error.The ifu precautions, "exercise care in handling the catheter during a procedure to reduce the possibility of accidental breakage.".
Event or Problem Description
Complex pci of the rca.Difficulty engaging a 6fr guide catheter.Once engaged used 6fr trapliner for added support, but minimal extension was outside of the guide catheter.We were unsuccessful in getting microcatheter past lesion so removed trapliner in order to use a rotational atherectomy system.Trapliner was then reinserted and resistance was felt in the last 10cm of the microcatheter, but there were no issues with continuing.The trapliner balloon was then inflated to trap the wire and in order to trap in the catheter, however, the balloon wouldn't inflate.All trapliner balloon inflations were done at 14atm.It was determined that the trapliner needed to be removed to replace with a 6fr guideliner.During removal of the trapliner outside of the patient, the trapliner guide extension separated from the hypo-tube in the hemostasis valve.No injury or impact reported.

• Brand Name: TRAPLINER
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 9315640
• Report Number: 2134812-2019-00074
• Device Sequence Number: 1962024
• Product Code: DQY
• UDI-Device Identifier: 10841156102128
• UDI-Public: (01)10841156102128
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K161901
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/17/2019

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: 08/12/2021
• Device Model Number: 5566
• Device Catalogue Number: 5566
• Device Lot Number: 655328
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/17/2019
• Initial Report FDA Received Date: 11/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR