MAUDE Adverse Event Report: VASCULAR SOLUTIONS, LLC SPECTRE GUIDEWIRE

Model Number	7386
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 2134812-2021-00019 trapliner.Mdr 2134812-2021-00020 turnpike lp.
Additional Manufacturer Narrative
There was no product returned for this complaint.No returned product evaluation could be completed.A manufacturing record review was completed by supplier and no related non-conformances were found.No product was returned to vsi/teleflex for investigation.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 spectre.Based on limited procedural information, it is unknown if spectre gw 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: SPECTRE GUIDEWIRE
• Common Device Name: GUIDEWIRE
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 11457183
• Report Number: 2134812-2021-00018
• Device Sequence Number: 3597510
• Product Code: DQX
• UDI-Device Identifier: 20841156106505
• UDI-Public: (01)20841156106505
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K163444
• 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: Health Professional
• Device Expiration Date: 06/16/2022
• Device Model Number: 7386
• Device Lot Number: 675297
• 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: Life Threatening; Other
• Patient Age: 70 YR
• Patient Weight: 38