MAUDE Adverse Event Report: VASCULAR SOLUTIONS, LLC TURNPIKE LP; CATHETER

Model Number	5639
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	01/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing record will be reviewed, a follow-up report will be issued after the investigation is complete.
Event or Problem Description
As reported: during a cto pci index procedure for the cto-pci study of a long, severely calcific non-tortuous lesion located in the prox.Lad, the subject suffered an ellis iii perforation of the distal lad while attempting to traverse retrograde with a turnpike lp microcatheter (study device).Perforation appeared to be largely contained and staining into fat.No actions were taken and resulted in vessel hematoma and residual dissection noted.Resolved without further sequelae.No adverse events were reported at study 30-day follow-up visit.
Additional Manufacturer Narrative
Submission name correction: 2134812-2021-00030 turnpike lp.Incorrect: 2134812-2021-00030 manta.
Additional Manufacturer Narrative
No product was returned to for evaluation.A manufacturing record review was completed and no related non-conformances were found.Case details were reviewed.The vessel (prox.Lad) was severely calcific and non-tortuous.The patient endured an ellis iii perforation of the distal lad while attempting to traverse retrograde with a turnpike lp microcatheter.Per ifu it identifies vessel perforation as one of the potential adverse effects that may be associated with the use of the turnpike.Perforation appeared to be largely contained and staining into fat.No actions were taken.Subsequently, the outcome resulted in vessel hematoma and residual dissection.Ifu also identifies vessel dissection and septal hematoma as potential adverse events associated to the use of turnpike.It is unknown if the turnpike was damaged during use that could have contributed to the event or any other ancillary devices used in the case caused the event.The issue resolved without further sequelae.No adverse events reported post 30-day follow-up visit.Based on the information, the most likely root cause of the issue is undeterminable.

• Brand Name: TURNPIKE LP
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 11655055
• Report Number: 2134812-2021-00030
• Device Sequence Number: 14326507
• Product Code: DQY
• UDI-Device Identifier: 20841156105058
• UDI-Public: (01)20841156105058
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K191560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/25/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/15/2022
• Device Model Number: 5639
• Device Lot Number: 676826
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/25/2021
• Supplement Date Received by Manufacturer: 03/25/2021; 03/25/2021
• Initial Report FDA Received Date: 04/13/2021
• Supplement Report FDA Received Date: 07/27/2021; 07/27/2021
• 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: Other
• Patient Age: 73 YR
• Patient Weight: 82