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

Model Number 5640

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Atrial Fibrillation (1729)

Event Date 01/09/2021

Event Type  Injury  

Manufacturer Narrative

Manufacturing records will be reviewed.A follow-up report will be issued after the investigation is complete.

Event Description

As reported: during the study 30-day conducted on (b)(6) 2021 it was reported that 3 days post-procedure the patient suffered new onset of a-fib with rates to 120 bpm and frequent pvcs.This new onset of a-fib is probably attributed to the volume overload and myocardial manipulation performed during the index procedure performed on (b)(6) 2021 of a cto pci of the proximal rca in which a turnpike (study device), trapliner (study device), spectre guidewire (study device) and raider guidewire (study device) were used.Patient was treated with sync-cardioversion and medical management with amiodarone load.This event was resolved with no sequelae.Mdrs associated to: mdr 2134812-2021-00017 raider gw.Mdr 2134812-2021-00018 spectre gw.Mdr 2134812-2021-00019 trapliner.

Manufacturer Narrative

There was no product returned for this complaint.No returned product evaluation could be completed.The lot # was reviewed.There are no non-conformities related to this lot therefore supporting the device met material, assembly and performance specifications.Account stated that the new onset of a-fib is probably attributed to the volume overload and myocardial manipulation performed during the index procedure.The symptom is a heart rhythm related issue and not directly related to the use of turnpike.Based on limited procedural information, it is unknown if turnpike contributed to adverse event.Patient was treated with sync-cardioversion and medical management with amiodarone load.This event was resolved with no sequelae.Based on the information, the most likely root cause is undeterminable.

• Brand Name: TURNPIKE SPIRAL
• Type of Device: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 11457151
• MDR Text Key: 246967824
• Report Number: 2134812-2021-00020
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 20841156105089
• UDI-Public: (01)20841156105089
• Combination Product (y/n): N
• PMA/PMN Number: K191560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/10/2021

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?: No
• Device Operator: No Information
• Device Expiration Date: 08/11/2022
• Device Model Number: 5640
• Device Lot Number: 678642
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/10/2021
• Initial Date FDA Received: 03/10/2021
• Supplement Dates Manufacturer Received: 02/10/2021
• Supplement Dates FDA Received: 06/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 38