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

Model Number	5640
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Vessel Or Plaque, Device Embedded In (1204)
Date of Event	03/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was returned to vsi on 03/17/2020.Considering the recent events pertaining to covid-19, product inspection is paused and will not be evaluated at this time.The manufacturing record review was completed and no related nonconformances were found, supporting the device met material, assembly and performance.Specifications.A follow-up report will be submitted when product return investigation is completed.
Event or Problem Description
It was reported that the tip of the turnpike spiral broke off during a peripheral case.The turnpike spiral was being used in a cto lesion in a tortuous 4.0 mm posterior tibial artery, however further blood flow was unsuccessful.The physician attempted to balloon the vessel but, was unsuccessful.Once the turnpike spiral was stuck, an attempt to balloon over the broken portion was unsuccessful.Later during attempt,a guidewire had also fractured off inside the sheath but was able to be retrieved.No further complications were reported.
Additional Manufacturer Narrative
A supplemental investigation was completed (b)(6) 2020 inspecting the product, tip damage was confirmed.It was reported that a very small portion of the tip was missing, and remains in patient.Small delamination of the polymer at the tip was noted.Measurements were taken for the turnpike spiral catheter and found to be within specification.As per ifu: do not rotate the catheter more than two (2) consecutive 360°rotations in either direction if the distal tip becomes lodged and is not also rotating, as it may result in separation of the catheter, damage to the catheter, or vessel injury.Based on the information and supplemental investigation, the most likely root cause is operational context.

• Brand Name: TURNPIKE SPIRAL
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis, mn
• MDR Report Key: 9907583
• Report Number: 2134812-2020-00030
• Device Sequence Number: 14077795
• Product Code: DQY
• UDI-Device Identifier: M20656400
• UDI-Public: M20656400
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2020

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: 04/18/2021
• Device Model Number: 5640
• Device Lot Number: 647231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2020
• Initial Date Received by Manufacturer: 03/03/2020
• Supplement Date Received by Manufacturer: 03/03/2020
• Initial Report FDA Received Date: 03/31/2020
• Supplement Report FDA Received Date: 04/30/2020
• 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
• Patient Age: 81 YR
• Patient Weight: 136