MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY INC. VERSACROSS RF WIRE; CATHETER, SEPTOSTOMY

Model Number	VXW-35-230-P
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	10/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There is no evidence to suggest that the baylis medical devices caused or contributed to the reported incident.However, as a baylis medical devices were reported to be among the devices used in the procedure, baylis medical has decided to submit this report.There is no suspected device malfunction.Dhr review was completed for the lot in question and all the devices fulfilled all requirements prior to release.
Event or Problem Description
The versacross rf wire and versacross transseptal sheath were used during a mitraclip procedure.Upon transseptal access, a blood clot was observed on the devices on the left side of the heart.Heparin was administered and the versacross rf wire was retracted while aspirating.The clot was captured and no adverse reactions occurred.There is no evidence to suggest that the baylis medical devices caused or contributed to the reported incident.However, as a baylis medical devices were reported to be among the devices used in the procedure, baylis medical has decided to submit this report.A separate problem report has been submitted for the versacross transseptal sheath with the report number 9710452-2021-00051.

• Brand Name: VERSACROSS RF WIRE
• Common Device Name: CATHETER, SEPTOSTOMY
• Manufacturer (Section G): BAYLIS MEDICAL COMPANY INC.; 2775 matheson blvd. east; mississauga, ontario L4W 4 P7; CA L4W 4P7
• Manufacturer Contact: meghal khakhar ; 2775 matheson blvd. east; mississauga, ontario L4W 4-P7 ; CA L4W 4P7
• MDR Report Key: 12804159
• Report Number: 9710452-2021-00052
• Device Sequence Number: 17514182
• Product Code: DXF
• UDI-Device Identifier: 00685447003311
• UDI-Public: (01)00685447003311(17)240707(10)VXFA060721
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K150709
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/12/2021

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: 07/07/2024
• Device Model Number: VXW-35-230-P
• Device Lot Number: VXFA060721
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2021
• Initial Report FDA Received Date: 11/12/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Unknown