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

Model Number	5568
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing record was reviewed, there were no nonconformance related to this lot, therefore, supporting the device met material, assembly and performance specifications.A follow-up report will be issued after the investigation is complete.
Event or Problem Description
It was reported: a 8fr trapliner device was used during a cto pci study case.During a cto pci procedure on the study subject it is reported that the balloon of an 8f trapliner "blew apart".No further complications were reported.Additional information received 24aug2020: at the balloon of an 8f trapliner "blew apart." the lesion was located in the proximal rca, had a j-cto score of 1, there was no calcium or tortuosity present, lesion length was 40 mm.The case was successful with timi score at the beginning of the case of 0 and at the end of the case.When the device was removed from the patient it was noted that the balloon had ruptured and looked like it had separated.It is unknown when the rupture happened during the case.The device was disposed of at the end of the case and was not retrieved.An 8fr guidecatheter was used.No part of the device was noted to be left in the patient.The patient was discharged the next day with no sequelae.
Additional Manufacturer Narrative
No product was returned to vsi/teleflex for investigation.Therefore, a returned product evaluation was not completed.A picture was sent by the account confirming the balloon rupture.The account was inquired on the details of balloon damage, confirmation on fragments of balloon left inside guide catheter or anatomy of patient and rated burst pressure used to inflate it.The account stated that it is unknown when the rupture of the balloon occurred.No part of the device was noted to be left in the patient.No response was received on the rated burst pressure used to inflate the balloon.Based on the information and no product evaluation, the most likely root cause of the issue is undeterminable.

• Brand Name: TRAPLINER
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis, mn
• MDR Report Key: 10465430
• Report Number: 2134812-2020-00054
• Device Sequence Number: 19430808
• Product Code: DQY
• UDI-Device Identifier: 20841156102149
• UDI-Public: (01)20841156102149
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K161901
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2020

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: 03/27/2022
• Device Model Number: 5568
• Device Lot Number: 670611
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/07/2020
• Supplement Date Received by Manufacturer: 08/07/2020
• Initial Report FDA Received Date: 08/28/2020
• Supplement Report FDA Received Date: 11/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 101