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

Model Number	VLAK0014
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Perforation (2001); Thrombosis/Thrombus (4440)
Date of Event	03/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that during a procedure to treat atrial fibrillation, a versacross large access solution system was selected for use.The transeptal puncture was then performed and upon crossing the interatrial septum (ias), the wire was sent into the left inferior pulmonary vein (lipv), but the wire hit the tip of the limbus.The versacross system was exchanged for the watchman truseal double curve sheath, but prior to the watchman sheath crossing the ias, it was noted that a small hypermobile echodensity had formed on the tip of the limbus.It measured approximately 3.5 mm in length.The watchman sheath was still crossed into the left atrium (la), the wire was pulled back and replaced with a pigtail catheter into the left atrial appendage (laa).The aforementioned hypermobile echodensity was continuously observed and at this time was deemed a clot.Additional heparin was given and after roughly 5-10 minutes the decision was made to cancel the procedure.It was stated that this was caused by the wire hitting the tip of the limbus and that the patient was likely hypercoagulable.Another procedure will be scheduled.No further information was provided.The device was disposed and is not expected to be returned for laboratory analysis.
Additional Manufacturer Narrative
Based on additional information the device was updated from versacross large access solution to protrack pigtail wire.Correction to field f10 patient code: the code e2114 perforation has been added.Correction to field f10 patient code: serious injury.Additional information received on 20apr2023 indicated that the device involved was a pigtail wire.The patient is stable and doing well.The device will not be returned as it was determined that there was no issue with the device and it was discarded.
Event or Problem Description
It was reported that during a procedure to treat atrial fibrillation, the transeptal puncture was then performed and upon crossing the interatrial septum (ias), a baylis pigtail wire was sent into the left inferior pulmonary vein (lipv), but the wire hit the tip of the limbus.The versacross system was exchanged for the watchman truseal double curve sheath, but prior to the watchman sheath crossing the ias, it was noted that a small hypermobile echodensity had formed on the tip of the limbus.It measured approximately 3.5 mm in length.The watchman sheath was still crossed into the left atrium (la), the wire was pulled back and replaced with a pigtail catheter into the left atrial appendage (laa).The aforementioned hypermobile echodensity was continuously observed and at this time was deemed a clot.Additional heparin was given and after roughly 5-10 minutes the decision was made to cancel the procedure.It was stated that this was caused by the wire hitting the tip of the limbus and that the patient was likely hypercoagulable.Another procedure will be scheduled.The patient is stable and doing well.The device will not be returned as it was determined that there was no issue with the device.
Event or Problem Description
It was reported that during a procedure to treat atrial fibrillation, the transeptal puncture was then performed and upon crossing the interatrial septum (ias), a versacross rf wire was sent into the left inferior pulmonary vein (lipv), but the versacross rf wire hit the tip of the limbus.The versacross system was exchanged for the watchman truseal double curve sheath, but prior to the watchman sheath crossing the ias, it was noted that a small hypermobile echodensity had formed on the tip of the limbus.It measured approximately 3.5 mm in length.The watchman sheath was still crossed into the left atrium (la), the versacross rf wire was pulled back and replaced with a non-boston scientific pigtail catheter into the left atrial appendage (laa).The aforementioned hypermobile echodensity was continuously observed and at this time was deemed a clot.Additional heparin was given and after roughly 5-10 minutes the decision was made to cancel the procedure.It was stated that this was caused by the wire hitting the tip of the limbus and that the patient was likely hypercoagulable.Another procedure will be scheduled.The patient is stable and doing well.The device will not be returned as it was determined that there was no issue with the device.It was further reported that the confirmed product used for transseptal.
Additional Manufacturer Narrative
07jul2023 - based on additional information the device was updated from protrack pigtail wire to versacross large access solution.Additional information received on 07jul2023 indicated that the device involved was a versacross rf wire.

• Brand Name: VERSACROSS LARGE 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: 16735264
• Report Number: 2124215-2023-15365
• Device Sequence Number: 13993632
• Product Code: DXF
• UDI-Device Identifier: 00685447012535
• UDI-Public: 00685447012535
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 08/02/2023
• 2 Devices were Involved in the Event: 1 2

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: 12/10/2024
• Device Model Number: VLAK0014
• Device Lot Number: VLFB100123
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/17/2023
• Supplement Date Received by Manufacturer: 04/20/2023; 07/07/2023
• Initial Report FDA Received Date: 04/13/2023
• Supplement Report FDA Received Date: 05/08/2023; 08/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 66 YR
• Patient Sex: Female