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

Model Number	5640
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Atrial Fibrillation (1729)
Date of Event	01/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing records will be reviewed.A follow-up report will be issued after the investigation is complete.
Event or Problem 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.
Additional 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
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 11457151
• Report Number: 2134812-2021-00020
• Device Sequence Number: 3597509
• Product Code: DQY
• UDI-Device Identifier: 20841156105089
• UDI-Public: (01)20841156105089
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K191560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: No Information
• Device Expiration Date: 08/11/2022
• Device Model Number: 5640
• Device Lot Number: 678642
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/10/2021
• Supplement Date Received by Manufacturer: 02/10/2021
• Initial Report FDA Received Date: 03/10/2021
• Supplement Report FDA Received Date: 06/28/2021
• 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: 70 YR
• Patient Weight: 38