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

Lot Number	0033508401
Medical Device Problem Codes	Material Frayed (1262); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2024
Type of Reportable Event	Malfunction
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 that during a watchman procedure, a versacross connect access solution kit was selected for use.The femoral access was gained to track up to the superior vena cava (svc) and a bright echogenic flap was noted prior to the transseptal.It was initially thought that there was a possible thrombus formation on tip of sheath, so the entire system was withdrawn out of the patient's body.The sheath was aspirated, and no thrombus was noted.Upon removal, it was discovered that the versacross rf wire had skived and flayed off from its tip and the mid-section of it.Hence, to resolve the issue, a new versacross connect kit and watchman sheath were used and the procedure was completed successfully.No patient complications were reported.The device is expected to be returned for analysis.The rf wire was not used introduction to vein, a starter wire was used instead.No other issues were reported.
Additional Manufacturer Narrative
Upon receipt at boston scientific's post market laboratory, the versacross rf wire was first visually inspected, and it failed, since the insulation was noted to be damaged on wire body.Next, the device passed the dimensional test, as the wire was in spec for wire outer diameter, electrode height, heat shrink gap and proximal end.No evidence was found to indicate a manufacturing or design-related issue.The reported allegation is confirmed.The potential root cause cannot be determined with full certainty.There is a possibility that introducer metal cannula if used could cause this type of damage, however it was not confirmed.
Event or Problem Description
It was reported that during a watchman procedure, a versacross connect access solution kit was selected for use.The femoral access was gained to track up to the superior vena cava (svc) and a bright echogenic flap was noted prior to the transseptal.It was initially thought that there was a possible thrombus formation on tip of sheath, so the entire system was withdrawn out of the patient's body.The sheath was aspirated, and no thrombus was noted.Upon removal, it was discovered that the versacross rf wire had skived and flayed off from its tip and the mid-section of it.Hence, to resolve the issue, a new versacross connect kit and watchman sheath were used and the procedure was completed successfully.No patient complications were reported.The device is expected to be returned for analysis.The rf wire was not used introduction to vein, a starter wire was used instead.No other issues were reported.

• 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): BOSTON SCIENTIFIC CORPORATION; 2775 matheson blvd east; mississauga, on L4W 4 P7; CA L4W 4P7
• Manufacturer Contact: angela hinkley ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 19659000
• Report Number: 2124215-2024-40789
• Device Sequence Number: 12383095
• Product Code: DXF
• UDI-Device Identifier: 00685447012597
• UDI-Public: 00685447012597
• 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): 08/22/2024

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 Lot Number: 0033508401
• 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: 06/13/2024
• Supplement Date Received by Manufacturer: 08/12/2024
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Male