MAUDE Adverse Event Report: VASCULAR SOLUTIONS, INC. TRAPLINER CATHETER

Model Number	5566
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	05/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One trapliner was returned for investigation.The catheter push rod and the distal shaft were separated at the hypotube ribbon weld.The event description stated that the trapliner broke while removing it.The breaking point is at the connection of the push rod and the half-pipe.The ifu precautions; "exercise care in handling the catheter during a procedure to reduce the possibility of accidental breakage or kinking." the most likely root cause for this is damage during use.
Event or Problem Description
During the middle of the procedure and when removing from the guide it came apart.The push rod came apart at the weld connecting the push rod to the distal lumen.It came apart as it was exiting the guide catheter.No patient impact.

• Brand Name: TRAPLINER CATHETER
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC.; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 6615531
• Report Number: 2134812-2017-00049
• Device Sequence Number: 13663125
• Product Code: DQY
• UDI-Device Identifier: M20655660
• UDI-Public: +M20655660/$$3181116600383
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/08/2017

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: Physician
• Device Expiration Date: 11/16/2018
• Device Model Number: 5566
• Device Lot Number: 600383
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2017
• Initial Report FDA Received Date: 06/06/2017
• Patient Sequence Number: 1