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

Model Number	5638
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Devices from the lot number reported in mw5084730 were distributed to a significant number of different sites.As such, we were unable to identify the initial reporter and unable to obtain additional information about the event.A manufacturing record review did not identify any non-conformances related to this lot.This supports that the device met material, assembly, and performance specifications prior to shipment.Based on the limited information available, the cause of the event was unable to be determined.
Event or Problem Description
Mw5084730 received 21mar2019.No initial reporter information was documented on the medwatch received.The turnpike lp catheter was being used for pci in a severely calcified proximal right coronary artery lesion.The tip of the catheter broke off from the catheter.Several unsuccessful attempts were made to aspirate out the fragment.The patient was sent to the operating room for urgent coronary artery bypass grafting.

• Brand Name: TURNPIKE LP
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 8520567
• Report Number: 2134812-2019-00022
• Device Sequence Number: 16522843
• Product Code: DQY
• UDI-Device Identifier: M20656380
• UDI-Public: M20656380
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K151981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/21/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: 5638
• Device Lot Number: 630156
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/21/2019
• Initial Report FDA Received Date: 04/16/2019
• 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: Required Intervention