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	02/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device returned and evaluation is anticipated, however, not begun.
Event or Problem Description
The operator forgot to remove the ptca trapping balloon from the 8f guide catheter prior to delivering the trapliner.The trapliner shaft broke during the attempt to deliver it into the guide catheter.The ptca balloon was removed from the guide and the trapliner was then delivered into the rca, however the balloon wouldn't hold pressure.When the trapliner was removed from the guide, it separated into two pieces.The separation occurred between the balloon and the halfpipe.Reported no patient injury or impact with the trapliner and both pieces of the device were pulled out from the guide.The doctor forgot to take a trapping balloon out of the guide prior to inserting trapliner.Because there was no room within the guide, the trapliner was advanced against resistance and the hypo tube broke.
Additional Manufacturer Narrative
One trapliner was returned for investigation.The distal section was separated into two pieces.The product was contaminated with biological matter.Unable to inflate the balloon due to dried biological matter.The traveler was reviewed, there were no non-conformances associated to this event.Root cause investigation is associated to mis-use by clinician.

• Brand Name: TRAPLINER CATHETER
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC.; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 6383527
• Report Number: 2134812-2017-00026
• Device Sequence Number: 511819
• Product Code: DQY
• UDI-Device Identifier: M20655660
• UDI-Public: +M20655660/$$3181116600383
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2017

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: 02/15/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/08/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/07/2017
• Supplement Report FDA Received Date: 03/29/2017
• Patient Sequence Number: 1