MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY INC. VERSACROSS STEERABLE ACCESS SOLUTION; CATHETER, SEPTOSTOMY

Model Number	VSTK0018
Medical Device Problem Codes	Difficult to Remove (1528); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during an atrial fibrillation (a fib) ablation procedure to treat atrial fibrillation (a fib), a versacross steerable access solution kit was selected for use.Venous femoral access was gained using the standard j-tip 035 guidewire, then versacross sheath was advanced.The guidewire was removed and versacross radio frequency wire was advanced.The radio frequency was applied once and was unsuccessful at crossing the fossa.Second attempt was made and was successful crossing the fossa.Then the radio frequency wire was advanced into the left superior pulmonary vein (lspv) and advanced the dilator and sheath across the fossa.However, as the dilator and radio frequency wire was being removed, the radio frequency wire could not be retracted.On fluoro, it was noticed the wire was tied into a knot.It was reported that there were no defects in the wire, no unusual anatomy, no difficulty loading the rf wire.It is unknown if the dilator was shaped beforehand.Both attempts to cross were 1 second constant pulse, and the knot formed after getting access in the left atrium so the knot formed in the left atrium.To resolve, the dilator was advanced back as far as it could go up the wire to the knot, then retracted the wire/dilator together into the sheath.The device is expected to be returned for analysis.
Additional Manufacturer Narrative
Additional information to the mdr initial, follow-up 1mdr in block(s) b5, f10, h6 for the product investigation results: the device was returned for analysis.Analysis of the device found based on the information provided in the complaint summary as well as based on the results of the testing/inspections performed, the reported allegations can be confirmed.However, it cannot be concluded with certainty what the root cause of this event was.The complaint description notes that the wire was anchored in the lspv prior to discovering the knot.The instructions for use (dmr-01673 dmr vstk (pcs) 3.3) contains the following statement: "once the puncture is successfully completed, the versacross rf wire should be mechanically advanced without any rf power.Positioning in the left atrium is sufficient when the full distal curve and floppy section have crossed the septum and are observed in the left atrium.Echocardiographic guidance is also recommended." it is likely that the knot was formed when the wire was advanced into the lspv, as the diameter of the vasculature is smaller than that of the left atrium, which is the suggested anchor location for the wire.Therefore, the pigtail curl may have been compressed by the anchoring anatomy and thus caused a knot as the dilator was being navigated to advance over the wire.Supplemental mdr is required to report investigation results.Mdr aware date 04jul2023.
Event or Problem Description
It was reported during an atrial fibrillation (a fib) ablation procedure to treat atrial fibrillation (a fib), a versacross steerable access solution kit was selected for use.Venous femoral access was gained using the standard j-tip 035 guidewire, then versacross sheath was advanced.The guidewire was removed and versacross radio frequency wire was advanced.The radio frequency was applied once and was unsuccessful at crossing the fossa.Second attempt was made and was successful crossing the fossa.Then the radio frequency wire was advanced into the left superior pulmonary vein (lspv) and advanced the dilator and sheath across the fossa.However, as the dilator and radio frequency wire was being removed, the radio frequency wire could not be retracted.On fluoro, it was noticed the wire was tied into a knot.It was reported that there were no defects in the wire, no unusual anatomy, no difficulty loading the rf wire.It is unknown if the dilator was shaped beforehand.Both attempts to cross were 1 second constant pulse, and the knot formed after getting access in the left atrium so the knot formed in the left atrium.To resolve, the dilator was advanced back as far as it could go up the wire to the knot, then retracted the wire/dilator together into the sheath.The device is expected to be returned for analysis.The device was returned for analysis.Analysis of the device found based on the information provided in the complaint summary as well as based on the results of the testing/inspections performed, the reported allegations can be confirmed.However, it cannot be concluded with certainty what the root cause of this event was.The complaint description notes that the wire was anchored in the lspv prior to discovering the knot.The instructions for use (dmr-01673 dmr vstk (pcs) 3.3) contains the following statement: "once the puncture is successfully completed, the versacross rf wire should be mechanically advanced without any rf power.Positioning in the left atrium is sufficient when the full distal curve and floppy section have crossed the septum and are observed in the left atrium.Echocardiographic guidance is also recommended." it is likely that the knot was formed when the wire was advanced into the lspv, as the diameter of the vasculature is smaller than that of the left atrium, which is the suggested anchor location for the wire.Therefore, the pigtail curl may have been compressed by the anchoring anatomy and thus caused a knot as the dilator was being navigated to advance over the wire.Supplemental mdr is required to report investigation results.Mdr aware date 04jul2023.
Event or Problem Description
It was reported during an atrial fibrillation (a fib) ablation procedure to treat atrial fibrillation (a fib), a versacross steerable access solution kit was selected for use.Venous femoral access was gained using the standard j-tip 035 guidewire, then versacross sheath was advanced.The guidewire was removed and versacross radio frequency wire was advanced.The radio frequency was applied once and was unsuccessful at crossing the fossa.Second attempt was made and was successful crossing the fossa.Then the radio frequency wire was advanced into the left superior pulmonary vein (lspv) and advanced the dilator and sheath across the fossa.However, as the dilator and radio frequency wire was being removed, the radio frequency wire could not be retracted.On fluoro, it was noticed the wire was tied into a knot.It was reported that there were no defects in the wire, no unusual anatomy, no difficulty loading the rf wire.It is unknown if the dilator was shaped beforehand.Both attempts to cross were 1 second constant pulse, and the knot formed after getting access in the left atrium so the knot formed in the left atrium.To resolve, the dilator was advanced back as far as it could go up the wire to the knot, then retracted the wire/dilator together into the sheath.The device is expected to be returned for analysis.It was further reported that there were no defects in the wire, no unusual anatomy, no difficulty loading the rf wire.Both attempts to cross were one second constant pulse, and the knot formed after getting access in the left atrium so the knot formed in the left atrium.The procedure was very "textbook" besides having to apply rf twice.The drop to the fossa was not unusually large either.The procedure was performed without floroscopy, so the physician reied solely on the markers on the wire.No resistance encountered at any point in the procedure prior to the knot being discovered and no difficulties with imaging during the procedure.
Additional Manufacturer Narrative
Correction clarifying additional information received in b5 event description.The device was returned for analysis.Visual inspection of the distal end confirm a knot formed at the distal end of the pigtail curve.The device met its specifications for wire body od, proximal end od, electrode height, and electrode/heat shrink gap.Based on the information provided in the complaint summary as well as based on the results of the testing/inspections performed, the reported allegations can be confirmed.However, it cannot be concluded with certainty what the root cause of this event was.The complaint description notes that the wire was anchored in the lspv prior to discovering the knot.The instructions for use (dmr-01673 dmr vstk (pcs) 3.3) contains the following statement:"once the puncture is successfully completed, the versacross rf wire should be mechanically advanced without any rf power.Positioning in the left atrium is sufficient when the full distal curve and floppy section have crossed the septum and are observed in the left atrium.Echocardiographic guidance is also recommended." it is likely that the knot was formed when the wire was advanced into the lspv, as the diameter of the vasculature is smaller than that of the left atrium, which is the suggested anchor location for the wire.Therefore, the pigtail curl may have been compressed by the anchoring anatomy and thus caused a knot as the dilator was being navigated to advance over the wire.

• Brand Name: VERSACROSS STEERABLE ACCESS SOLUTION
• Common Device Name: CATHETER, SEPTOSTOMY
• Manufacturer (Section D): BAYLIS MEDICAL COMPANY INC.; 5959 trans-canada highway; montreal H4T 1 A1; CA H4T 1A1
• Manufacturer (Section G): BAYLIS MEDICAL COMPANY INC.; 5825 explorer drive; mississauga on L4W 5 P6; CA L4W 5P6
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 17083246
• Report Number: 2124215-2023-28123
• Device Sequence Number: 6244140
• Product Code: DXF
• UDI-Device Identifier: 00685447012092
• UDI-Public: 00685447012092
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/27/2025
• Device Model Number: VSTK0018
• Device Lot Number: VKFE120123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/16/2023
• Supplement Date Received by Manufacturer: 07/04/2023; 07/04/2023
• Initial Report FDA Received Date: 06/07/2023
• Supplement Report FDA Received Date: 08/01/2023; 08/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown