MAUDE Adverse Event Report: VASCULAR SOLUTIONS, INC TRAPLINER CATHETER

Model Number	5567
Medical Device Problem Codes	Detachment Of Device Component (1104); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A manufacturing record review was completed and zero nonconformances related to this failure were found.The returned product evaluation confirmed the shaft breakage at the hypotube ribbon weld.The ifu states to inspect the catheter for damage prior to use, and there was no damage noted before loading it on the guidewire.The ifu precautions states; "exercise care in handling the catheter during a procedure to reduce the possibility of accidental breakage or kinking." based on the returned product evaluation and the information provided the most likely cause for the failure is damage during use.
Event or Problem Description
The trapliner push rod broke while loading it on the guidwire.Did not observe any rough handling of the catheter prior to this event.The trapliner broke while loading on the wire outside the patient.No patient interaction.It was not used in this case.Then used a guideliner and a trapping balloon.

• Brand Name: TRAPLINER CATHETER
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 6972596
• Report Number: 2134812-2017-00086
• Device Sequence Number: 1197198
• Product Code: DQY
• UDI-Device Identifier: M20655670
• UDI-Public: M20655670
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,user f
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/03/2017

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: No Information
• Device Expiration Date: 02/09/2019
• Device Model Number: 5567
• Device Lot Number: 602124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/03/2017
• Initial Report FDA Received Date: 10/24/2017
• Patient Sequence Number: 1