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

Model Number 5640

Device Problem Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/23/2019

Event Type  Injury  

Manufacturer Narrative

One-unit of turnpike, model 5640 was returned to vsi for evaluation.On inspecting the product, it was confirmed that the tip was separated.The tip is also twisted and deformed exposing the ptfe liner.The damage on the catheter tip indicates torquing the catheter against resistance.A guidewire used along with turnpike was also examined.The tip of the turnpike was attached to the guidewire confirming separation.A manufacturing record review was completed and no related nonconformances were found.There are no non-conformances related to this lot therefore supporting the device met material, assembly and performance specifications.The most likely cause of the reported event was that the catheter was rotated excessively while the distal tip was fixed.The turnpike ifu warns; "do not rotate the catheter more than two (2) consecutive 360° rotations in either direction if the distal tip is not also rotating and advancing, as it may result in separation of the catheter, damage to the catheter, or vessel injury." the most likely root cause can therefore be related to user error and operational context.

Event Description

As reported: physician was performing a complex multivessel intervention in a heavily calcified lesion when the tip of the turnpike spiral broke off.They were able to retrieve the tip and the patient was not harmed.Additionally, the lab manager who reported, stated there was another turnpike spiral tip separation recently, however, she doesn't have specific information.This report is associated to mdr 2134812-2020-00004 and mdr 2134812-2020-00005.

• Brand Name: TURNPIKE SPIRAL
• 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: 9618022
• MDR Text Key: 176762264
• Report Number: 2134812-2020-00005
• Device Sequence Number: 1
• Product Code: DQY
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/18/2021
• Device Model Number: 5640
• Device Lot Number: 647230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/02/2019
• 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
• Patient Age: 65 YR