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

Model Number	5566
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been returned, but not yet fully evaluated.Further information will follow once the analysis has been completed.No conclusion can be drawn at this time.
Event or Problem Description
Physician accessed femoral artery.The trapliner became detached at the balloon during a pci procedure.Device was removed in its entirety; snared cable and removed.No delay reported, also, no complications reported.It's reported as no medical intervention required.
Additional Manufacturer Narrative
One unit model 5566 trapliner catheter was returned to vsi for evaluation.The device was examined and was found to be separated at the hypotube ribbon weld; a bend was observed at the breakage point of the device.A manufacturing record review was completed and zero related nonconformances were found.A returned product evaluation was also completed; the trapliner was examined and found to be separated.The breakage, however, was found to be distal of the balloon at the hypotube ribbon weld, not at the balloon as stated in the complaint.A bend was observed at the breakage point, supporting that the breakage was likely caused by a bend to the pushrod of the device.

• Brand Name: TRAPLINER
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 8091235
• Report Number: 2134812-2018-00087
• Device Sequence Number: 1437766
• Product Code: DQY
• UDI-Device Identifier: M20655660
• UDI-Public: M20655660
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K161901
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2018

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: Health Professional
• Device Expiration Date: 10/26/2019
• Device Model Number: 5566
• Device Lot Number: 612698
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2018
• Initial Date Received by Manufacturer: 10/22/2018
• Supplement Date Received by Manufacturer: 10/22/2018
• Initial Report FDA Received Date: 11/20/2018
• Supplement Report FDA Received Date: 01/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention