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

Model Number 5638

Device Problem Separation Problem (4043)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/01/2019

Event Type  Injury  

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 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
• Type of Device: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer (Section G): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer Contact: mary haufek ; 6464 sycamore court north; minneapolis, MN 55369 ; 7636564230
• MDR Report Key: 8520567
• MDR Text Key: 142193063
• Report Number: 2134812-2019-00022
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: M20656380
• UDI-Public: M20656380
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151981
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: 5638
• Device Lot Number: 630156
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention