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

Model Number	5568
Medical Device Problem Codes	Solder Joint Fracture (2324); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Trapliner was not returned to vsi for evaluation.A manufacturing record review was completed and no related nonconformances were found, supporting the device met material, assembly and performance specifications.If the device returns a follow-up report will be submitted.
Event or Problem Description
Trapliner broke at the transition point between the hypo-tube and halfpipe.No injury or impact reported.Additional information received 19dec19: the device broke putting into the hemostasis valve and was able to be pulled out by hand.There was no resistance felt during a calcified cto of rca that had minimal tortuosity.
Additional Manufacturer Narrative
A manufacturing record review was completed and no related nonconformances were found.A returned product evaluation was completed.On inspecting the product, the trapliner was broken at the transition point between the hypotube and halfpipe.The ifu precautions, "exercise care in handling the catheter during a procedure to reduce the possibility of accidental breakage." the most likely root cause for the separation is operational context and unintended user error.

• Brand Name: TRAPLINER
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 9503663
• Report Number: 2134812-2019-00082
• Device Sequence Number: 16644712
• Product Code: DQY
• UDI-Device Identifier: 20841156102149
• UDI-Public: (01)20841156102149
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,Followup
• Report Date (Section B): 12/02/2019

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: 08/05/2021
• Device Model Number: 5568
• Device Lot Number: 654644
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2019
• Initial Date Received by Manufacturer: 11/27/2019
• Supplement Date Received by Manufacturer: 11/27/2019
• Initial Report FDA Received Date: 12/20/2019
• Supplement Report FDA Received Date: 01/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 111