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

Model Number	5566
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A manufacturing record review was completed and zero nonconformances were found therefore supporting the device met material, assembly and performance specifications.A product evaluation was also completed and confirmed the complaint received.The catheter pushrod and distal shaft were separated at the hypo tube ribbon weld outside of the body during pretesting.The ifu precautions, "exercise care in handling the catheter during a procedure to reduce the possibility of accidental breakage." based on the returned product evaluation and the information provided, the most likely root cause for this failure is therefore damage during use.No patient impact or injury was reported.
Event or Problem Description
Prior to use on a patient, (pre-testing) trapliner separated at transition from hypo tube to lumen prior to attempting to advance it onto the wire and into the guide.Procedure completed successfully, and patient is fine.The procedure was completed with a new trapliner.The device was never advanced on the wire.

• Brand Name: TRAPLINER
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 7685335
• Report Number: 2134812-2018-00047
• Device Sequence Number: 1316573
• Product Code: DQY
• UDI-Device Identifier: M20655660
• UDI-Public: M20655660
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/15/2018

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: Health Professional
• Device Expiration Date: 08/29/2019
• Device Model Number: 5566
• Device Lot Number: 611373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/15/2018
• Initial Report FDA Received Date: 07/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1