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

Model Number	VXW-35-230-P-WM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	08/31/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A blood clot was observed on the versacross rf wire (rf wire) used for transseptal puncture during a left atrial appendage closure (laac) procedure.Heparin was administered and transseptal puncture was successfully completed with the rf wire.Additional heparin was administered.Subsequently, a clot was noted on the tip of the rf wire.The versacross connect transseptal dilator (vxa dilator) and watchman access sheath (boston scientific) used with the rf wire were advanced through the septum into the left atrium.The vxa dilator was removed from the patient and the physician aspirated the clot on the rf wire.After the clot was no longer visualized, the watchman access sheath was removed and flushed.The vxa dilator and watchman access sheath were re-inserted.After septal dilation, the vxa dilator was removed with the watchman access sheath remaining in patient to proceed with the laac procedure.Another clot was observed on the watchman access sheath via transesophageal echocardiogram.The clot was aspirated.The laac procedure continued and was successfully completed.No patient harm was noted post procedure.As a baylis medical device was reported to be among the devices used in the procedure, baylis medical has decided to submit this report.
Additional Manufacturer Narrative
As a baylis medical device was reported to be among the devices used in the procedure, baylis medical has devices to submit this report.A dhr review was completed for the lot in question and all the devices fulfilled all requirements prior to release.

• Brand Name: VERSACROSS RF WIRE
• Common Device Name: CATHETER, SEPTOSTOMY
• Manufacturer (Section D): BAYLIS MEDICAL COMPANY INC.; 5959 trans-canada highway; montreal, quebec H4T 1 A1; CA H4T 1A1
• 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: 15508475
• Report Number: 3019751610-2022-00034
• Device Sequence Number: 5843792
• Product Code: DXF
• UDI-Device Identifier: 00685447010531
• UDI-Public: (01)00685447010531(17)241126(10)VMFA250322
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/29/2022

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: 03/23/2025
• Device Model Number: VXW-35-230-P-WM
• Device Lot Number: VMFA250322
• 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: 08/31/2022
• Initial Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2022
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown