MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY INC. VERSACROSS CONNECT LAAC ACCESS SOLUTION; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Medical Device Problem Codes	Difficult to Remove (1528); Device-Device Incompatibility (2919); Difficult to Advance (2920); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a watchman procedure to treat atrial fibrillation (a fib), a versacross connect kit was selected for use.The mechanical j-wire was placed into superior vena cava (svc).Then the watchman sheath and versacross dilator was positioned in superior vena cava (svc).When the wire was attempted to be removed, it got stuck and could not be advanced or retracted.Therefore, both the dilator and wire were removed and replaced with the new system.The procedure was completed successfully and no patient complications reported.The device is expected to be returned for analysis.It was further noted there were no issues upon removal from packaging.It is suspected that the wire may have kinked when bringing the dilator/sheath up the tortuous anatomy.The guidewire distal end protruding from dilator.The watchman sheath remained in the body and was not replaced.
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.
Additional Manufacturer Narrative
Supplemental mdr submitted to report investigation results (mdr aware date: 26oct2023).The device was returned for analysis.The guidewire wire returned in one piece with coil stacking and numerous kinks.The versacross dilator was also severely kinked at the distal tip.This issue of mechanical guidewire to versacross dilator compatibility/stuck was investigated as part of capa.
Event or Problem Description
It was reported that during a watchman procedure to treat atrial fibrillation (a fib), a versacross connect kit was selected for use.The mechanical j-wire was placed into superior vena cava (svc).Then the watchman sheath and versacross dilator was positioned in superior vena cava (svc).When the wire was attempted to be removed, it got stuck and could not be advanced or retracted.Therefore, both the dilator and wire were removed and replaced with the new system.The procedure was completed successfully and no patient complications reported.The device is expected to be returned for analysis.It was further noted there were no issues upon removal from packaging.It is suspected that the wire may have kinked when bringing the dilator/sheath up the tortuous anatomy.The guidewire distal end protruding from dilator.The watchman sheath remained in the body and was not replaced.

• Brand Name: VERSACROSS CONNECT LAAC ACCESS SOLUTION
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): BAYLIS MEDICAL COMPANY INC.; 5959 trans-canada highway; montreal, qc 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: 17568130
• Report Number: 2124215-2023-43655
• Device Sequence Number: 6939443
• Product Code: DRE
• UDI-Device Identifier: 00685447012580
• UDI-Public: 00685447012580
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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,Followup
• Report Date (Section B): 11/09/2023

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/26/2023
• Supplement Date Received by Manufacturer: 10/26/2023
• Initial Report FDA Received Date: 08/17/2023
• Supplement Report FDA Received Date: 11/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown