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

Lot Number	0034141056
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	10/11/2024
Type of Reportable Event	Serious Injury
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.A separate problem report will be filed for the versacross rf wire.
Event or Problem Description
It was reported during a pulse field ablation procedure, a versacross connect for laac kit was selected for use.The physician performed transseptal puncture successfully.The wire was across and the physician had some difficulty getting the dilator to cross the septum due to thick tissue.It was attempted multiple times to push the dilator through the septum with no success.The vers across rf wire was left across and the versacross dilator was pulled out.Then it was decided to use the faradrive dilator to see if its stiffer tip would allow for crossing into the left atrium.While prepping the faradrive dilator, a thrombus was noted at the transseptal site.The physician was unsure if the thrombus was attached to the wire or the septum, hence the wire was removed.Thrombus was detached upon removal of the wire and was not seen remaining in the right atrium with intracardiac echocardiography (ice) or upon removal and flushing of sheath/dilator.There was no intervention taken.The patient was monitored; and expected to fully recover and it has been discharged.The device is not expected to be returned for analysis.A full dose of heparin was administered before tsp.No interventions were taken.

• Brand Name: VERSACROSS CONNECT LAAC ACCESS SOLUTION
• 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; zona franca la lima; cartgo, 03 30106 ; CS 30106
• Manufacturer Contact: angela hinkley ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 20599830
• Report Number: 2124215-2024-68815
• Device Sequence Number: 6528347
• Product Code: DRE
• UDI-Device Identifier: 00685447012573
• UDI-Public: 00685447012573
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K220414
• 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
• Report Date (Section B): 11/04/2024

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 Lot Number: 0034141056
• 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: 10/11/2024
• Initial Report FDA Received Date: 11/04/2024
• Date Device Manufactured: 02/21/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown