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

Model Number	5566
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/07/2017
Type of Reportable Event	Serious Injury
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 in the body at the connection point of the push rod and the half-pipe.Additional information confirmed the case that the collar of the trapliner was extended out of the distal end of the guide catheter (in the lima) prior to the separation.The ifu precautions, "never advance the trapliner catheter more than 10 cm beyond the tip of the guide catheter, as the trapliner catheter may become lodged in the guide catheter making it difficult to remove." the root cause for this failure is clinician misuse.
Event or Problem Description
Intervention of a lesion at the anastomosis of the lima to the lad.The trapliner broke in the body at the connection of the push rod to the half pipe.Both parts of the trapliner were removed without patient impact.Parts were removed by inserting a balloon and pulled parts out.

• Brand Name: TRAPLINER CATHETER
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC.; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 6541344
• Report Number: 2134812-2017-00043
• Device Sequence Number: 6415
• Product Code: DQY
• UDI-Device Identifier: M20655660
• UDI-Public: +M20655660/$$3190209602123Y
• Combination Product (Y/N): N
• 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): 04/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 02/09/2019
• Device Model Number: 5566
• Device Lot Number: 602123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2017
• Initial Report FDA Received Date: 05/03/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Weight: 64