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	03/01/2018
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; "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
We were using an 8fr launcher guide and a turnpike lp with a run through wire.The 7f trapliner just snapped as we were advancing through the guide.We weren't even pushing hard.Likely just defective.Didn't ruin the case.Used an 8fr trapliner that worked well.It broke into 2 pieces when they were inserting it into the guide.Reported as: i dont think the catheter was actually in the body.Patient outcome was reported as fine, patient not affected.

• Brand Name: TRAPLINER CATHETER
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC.; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 7380925
• Report Number: 2134812-2018-00017
• Device Sequence Number: 11176983
• Product Code: DQY
• UDI-Device Identifier: M20655670
• UDI-Public: M20655670
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 03/02/2018

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: Physician
• Device Expiration Date: 06/02/2019
• Device Model Number: 5567
• Device Lot Number: 608319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/02/2018
• Initial Report FDA Received Date: 03/29/2018
• Patient Sequence Number: 1