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

Catalog Number	5566
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	12/05/2019
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
As reported: the trapliner shaft broke during insertion in a cto case of the rca.Additional information received 17dec19 there was no resistance felt however, the vessel was calcified.The trapliner retrieved after insertion, it came out manually without difficulty.Patient outcome is reported as fine, with a successful fix of the rca.
Additional Manufacturer Narrative
Additional information received 15jan2020 was just informed that, unfortunately, the trapliner in question was accidentally disposed of by account.
Event or Problem Description
Additional information received 15jan2020 was just informed that, unfortunately, the trapliner in question was accidentally disposed of by account.

• Brand Name: TRAPLINER
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 9512228
• Report Number: 2134812-2019-00083
• Device Sequence Number: 13552916
• Product Code: DQY
• UDI-Device Identifier: 20841156102125
• UDI-Public: (01)20841156102125
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 12/05/2019

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: 10/30/2021
• Device Catalogue Number: 5566
• Device Lot Number: 661381
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/05/2019
• Supplement Date Received by Manufacturer: 12/05/2019
• Initial Report FDA Received Date: 12/23/2019
• Supplement Report FDA Received Date: 01/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 142