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

Model Number	5639
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	10/06/2020
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
As reported: during retrograde cto pci of the proximal rca, a septal hematoma was noted on angiography.Procedure being performed was reverse cart and the site felt that the hematoma was caused by a guidewire which was inserted into the septal via a turnpike lp microcatheter (study device).Though the site stated that the guidewire was the cause of the septal hematoma, it is unclear which device was responsible.The patient suffered no adverse effects and was discharged home with no sequelae.
Additional Manufacturer Narrative
There was no product returned for this complaint.No returned product evaluation could be completed.The lot # was reviewed, and there was no non-conformances related to this lot therefore, supporting the device met material, assembly and performance specifications.Per ifu: septal hematoma is identified as one of the potential adverse effects that maybe associated with the use of the turnpike.Account felt that the hematoma was caused by the guidewire which was inserted into the septal via a turnpike lp microcatheter (study device).However, it is unclear which device was responsible.Patient suffered no adverse events and/or any other sequelae.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: 11425629
• Report Number: 2134812-2021-00013
• Device Sequence Number: 17114285
• Product Code: DQY
• UDI-Device Identifier: 20841156105058
• UDI-Public: (01)20841156105058
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Report Date (Section B): 02/04/2021

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: 04/07/2022
• Device Model Number: 5639
• Device Lot Number: 671179
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/04/2021
• Supplement Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 03/05/2021
• Supplement Report FDA Received Date: 06/10/2021
• 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: Life Threatening
• Patient Age: 89 YR
• Patient Weight: 67