MAUDE Adverse Event Report: BAYLIS MEDICALE CIE INC VERSACROSS CONNECT ACCESS SOLUTION FOR FARADRIVE; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number	VXAK0045
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	12/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported a thrombus was noted.During atrial fibrillation and typical atrial flutter ablation procedure, a versacross; connect for faradrive kit was selected for use.A transesophageal echocardiogram (tee) was performed prior to procedure to rule out presence of left atrial appendage (laa) thrombus however the physician did not examine the right atrium for presence of thrombus.No thrombus was noted in the laa.The femoral access was obtained.Three short sheaths were introduced over short wires.Then an 8fr short sheath was exchanged for the faradrive sheath over the versacross rf wire.Upon approaching the intra atrial septum, a thrombus was noted on the tip of the versacross connect dilator and/or faradrive sheath.The faradrive sheath and versacross wire were removed from the body.The patient was then anticoagulated to achieve an activated clotting time (act) of greater than 350sec.The transseptal puncture was performed using the original sheath, however a new versacross wire as original one was mistakenly bent by the scrub tech upon removing from the body.An act of greater than 375 sec was maintained during the remainder of the procedure.The procedure was then completed with no further issues.The device is expected to be returned for analysis.The versacross rf wire tip was not exposed outside of the dilator.In the physician opinion, the physician stated that he felt 'the sheath was pro thrombogenic.' however, the versacross connect system was being used in conjunction with the faradrive sheath.
Event or Problem Description
It was reported a thrombus was noted.During atrial fibrillation and typical atrial flutter ablation procedure, a versacross; connect for faradrive kit was selected for use.A transesophageal echocardiogram (tee) was performed prior to procedure to rule out presence of left atrial appendage (laa) thrombus however the physician did not examine the right atrium for presence of thrombus.No thrombus was noted in the laa.The femoral access was obtained.Three short sheaths were introduced over short wires.Then an 8fr short sheath was exchanged for the faradrive sheath over the versacross rf wire.Upon approaching the intra atrial septum, a thrombus was noted on the tip of the versacross connect dilator and/or faradrive sheath.The faradrive sheath and versacross wire were removed from the body.The patient was then anticoagulated to achieve an activated clotting time (act) of greater than 350sec.The transseptal puncture was performed using the original sheath, however a new versacross wire as original one was mistakenly bent by the scrub tech upon removing from the body.An act of greater than 375 sec was maintained during the remainder of the procedure.The procedure was then completed with no further issues.The device is expected to be returned for analysis.The versacross rf wire tip was not exposed outside of the dilator.In the physician opinion, the physician stated that he felt 'the sheath was pro thrombogenic.' however, the versacross connect system was being used in conjunction with the faradrive sheath.The device was returned for analysis.
Additional Manufacturer Narrative
The device was returned for analysis.Dilator flushed properly before and after decontamination.Analysis of the device found there were no defects at the distal tip of the dilator and the inside diameter passed the design specification indicating that there were no defects related to the dilator tip that would potentially lead to thrombosis.Based on the media provided in the complaint displaying imaging of thrombosis, the allegation of adverse events are confirmed and through the labeling review are listed within the instruction for use (ifu).

• Brand Name: VERSACROSS CONNECT ACCESS SOLUTION FOR FARADRIVE
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): BAYLIS MEDICALE CIE INC; 5959 trans-canada highway; montreal H4T 1 A1; CA H4T 1A1
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2775 matheson blvd east; mississauga, on L4W 4 P7; CA L4W 4P7
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 21004087
• Report Number: 2124215-2024-81485
• Device Sequence Number: 6810254
• Product Code: DRE
• UDI-Device Identifier: 00685447019060
• UDI-Public: 00685447019060
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K233647
• 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
• Report Date (Section B): 03/20/2025

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 Model Number: VXAK0045
• Device Catalogue Number: VXAK0045
• Device Lot Number: 0034491404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2024
• Supplement Date Received by Manufacturer: 02/28/2025
• Initial Report FDA Received Date: 12/23/2024
• Supplement Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2024
• 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 Sex: Unknown