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

Lot Number	VMFA140723
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Integrity Problem (2978)
Health Effect - Clinical Code	Asystole (4442)
Date of Event	12/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a versacross connect access solution was selected for use during a watchman case.The versacross connect rf wire was used and put it through a non-boston scientific 18g access needle at femoral access likely causing the shearing (intact and peeled).Thus, a second versacross rf wire was selected for use and the same issue happened.As an alternative, physician switch to a non-boston scientific.032/sl1/brk, and upon inserting this system physician accidentally bumped atrioventricular (av) node causing instant asystole in the patient.Therefore, a cpr was needed and patients pulse returned.Three more times pre-transseptal patient went into asystole and pulse returned each time.Once transseptal, no more asystole occurrences happened and the watchman was implanted successfully.No other issues were reported.The device is not expected to be returned for analysis.In the physician's opinion, the versacross rf wires did not contribute to the adverse event.The issue with the wire happened due to the insertion of the wire through an 18g access needle.Other the resuscitation, a pacer wire was inserted and utilized on the last 3 asystolic events.No other damage was noted on the wires before or after the insulation damage was discovered.The patient did not have any mechanical hardware in their ra that the wire got caught in.
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.
Additional Manufacturer Narrative
The device was not returned for analysis.However, based on the media provided, the reported allegation for coating issue was confirmed.Thus, a supplemental mdr will be filed (mdr aware date is 22jan2024).
Event or Problem Description
It was reported that a versacross connect access solution was selected for use during a watchman case.The versacross connect rf wire was used and put it through a non-boston scientific 18g access needle at femoral access likely causing the shearing (intact and peeled).Thus, a second versacross rf wire was selected for use and the same issue happened.As an alternative, physician switch to a non-boston scientific.032/sl1/brk, and upon inserting this system physician accidentally bumped atrioventricular (av) node causing instant asystole in the patient.Therefore, a cpr was needed and patients pulse returned.Three more times pre-transseptal patient went into asystole and pulse returned each time.Once transseptal, no more asystole occurrences happened and the watchman was implanted successfully.No other issues were reported.The device is not expected to be returned for analysis.In the physician's opinion, the versacross rf wires did not contribute to the adverse event.The issue with the wire happened due to the insertion of the wire through an 18g access needle.Other the resuscitation, a pacer wire was inserted and utilized on the last 3 asystolic events.No other damage was noted on the wires before or after the insulation damage was discovered.The patient did not have any mechanical hardware in their ra that the wire got caught in.

• Brand Name: VERSACROSS CONNECT LAAC 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: 18490325
• Report Number: 2124215-2023-72646
• Device Sequence Number: 20630109
• Product Code: DXF
• UDI-Device Identifier: 00685447012573
• UDI-Public: 00685447012573
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Report Date (Section B): 02/13/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/03/2025
• Device Lot Number: VMFA140723
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/18/2023
• Supplement Date Received by Manufacturer: 01/22/2024
• Initial Report FDA Received Date: 01/10/2024
• Supplement Report FDA Received Date: 02/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Race: White