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

Model Number	5566
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no product returned for this complaint.No returned product evaluation could be completed.Based on limited information and no product returned, the most likely root cause as to what caused the flush portion to come off the catheter was undeterminable.
Event or Problem Description
It was reported that when the physician was advancing the trapliner, the flush portion completely came off the shaft.No further complications were reported.Associated to mdr 2134812-2020-00031 trapliner.
Additional Manufacturer Narrative
One unit of trapliner model 5566 was returned to vsi for evaluation.On inspecting the unit, blood particulates were found along the length of the catheter shaft.The trapliner was broken into two parts with a snap confirmed at the ribbon weld joint proximal to the half pipe.A manufacturing record review was completed and no related nonconformances were found.The ifu precautions, "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 information and product evaluation, the most likely root cause for the separation is operational context and unintended user error.

• Brand Name: TRAPLINER
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis, mn
• MDR Report Key: 9943224
• Report Number: 2134812-2020-00032
• Device Sequence Number: 2168132
• Product Code: DQY
• UDI-Device Identifier: 20841156102125
• UDI-Public: (01)20841156102125
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2020

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: 11/06/2021
• Device Model Number: 5566
• Device Lot Number: 661821
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2020
• Initial Date Received by Manufacturer: 03/12/2020
• Supplement Date Received by Manufacturer: 03/12/2020
• Initial Report FDA Received Date: 04/09/2020
• Supplement Report FDA Received Date: 05/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR