MAUDE Adverse Event Report: BAYLIS MEDICALE CIE INC VERSACROSS STEERABLE ACCESS SOLUTION; INTRODUCER, CATHETER

Lot Number	0034257628
Medical Device Problem Codes	Material Perforation (2205); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a versacross steerable access solution was selected for pulmonary vein isolation.During procedure, a non-boston scientific decapolar stj inquiry catheter was inserted into the versacrsoss sheath, placed into the coronary sinus, then the inquiry catheter was removed from the sheath.Blood was aspirated from the coronary sinus from the versacross sheath, and it was retracted from the coronary sinus and left in the right atrium.Thus, the non-boston scientific octoray was inserted into the versacross sheath to create an electroanatomical map of the right atrium, and once it was removed from the versacross sheath, a gray filament was removed from the valve of the versacross sheath.Both devices were then inspected, and no damage were noted to either.Therefore, the transseptal was achieved across to the left atrium and the versacross rf wire was exchanged for the octoray and an electroanatomical map was created of the left atrium.Once the octoray was removed from the versacfoss sheath, another gray-filament like structure was removed from the valve of the versacross sheath.Again, both devices were inspected and no issues were noted on them.The versacross was exchanged with the faradrive sheath over the versacross rf wire and the procedure continued as usual.The octoray was also inserted and removed through the faradrive sheath later in the procedure and no issues were reported.The procedure was complete successfully.No patient complications were reported.The device is expected to be returned for analysis.
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
The device was not returned for analysis.However, based on the media provided, the reported allegation of liner damage was confirmed.If there is any further relevant information obtained, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that a versacross steerable access solution was selected for pulmonary vein isolation.During procedure, a non-boston scientific decapolar stj inquiry catheter was inserted into the versacrsoss sheath, placed into the coronary sinus, then the inquiry catheter was removed from the sheath.Blood was aspirated from the coronary sinus from the versacross sheath, and it was retracted from the coronary sinus and left in the right atrium.Thus, the non-boston scientific octoray was inserted into the versacross sheath to create an electroanatomical map of the right atrium, and once it was removed from the versacross sheath, a gray filament was removed from the valve of the versacross sheath.Both devices were then inspected, and no damage were noted to either.Therefore, the transseptal was achieved across to the left atrium and the versacross rf wire was exchanged for the octoray and an electroanatomical map was created of the left atrium.Once the octoray was removed from the versacfoss sheath, another gray-filament like structure was removed from the valve of the versacross sheath.Again, both devices were inspected and no issues were noted on them.The versacross was exchanged with the faradrive sheath over the versacross rf wire and the procedure continued as usual.The octoray was also inserted and removed through the faradrive sheath later in the procedure and no issues were reported.The procedure was complete successfully.No patient complications were reported.The device is expected to be returned for analysis.
Event or Problem Description
It was reported that a versacross steerable access solution was selected for pulmonary vein isolation.During procedure, a non-boston scientific decapolar stj inquiry catheter was inserted into the versacrsoss sheath, placed into the coronary sinus, then the inquiry catheter was removed from the sheath.Blood was aspirated from the coronary sinus from the versacross sheath, and it was retracted from the coronary sinus and left in the right atrium.Thus, the non-boston scientific octoray was inserted into the versacross sheath to create an electroanatomical map of the right atrium, and once it was removed from the versacross sheath, a gray filament was removed from the valve of the versacross sheath.Both devices were then inspected, and no damage were noted to either.Therefore, the transseptal was achieved across to the left atrium and the versacross rf wire was exchanged for the octoray and an electroanatomical map was created of the left atrium.Once the octoray was removed from the versacfoss sheath, another gray-filament like structure was removed from the valve of the versacross sheath.Again, both devices were inspected and no issues were noted on them.The versacross was exchanged with the faradrive sheath over the versacross rf wire and the procedure continued as usual.The octoray was also inserted and removed through the faradrive sheath later in the procedure and no issues were reported.The procedure was complete successfully.No patient complications were reported.The device is expected to be returned for analysis.The device has returned for analysis.
Additional Manufacturer Narrative
The device was returned for analysis.Upon receipt at our post market quality assurance laboratory, both versacross dilator and sheath flushed properly before and after decontamination.During visual inspection, there was no damage noted on the stopcock handle or sheath shaft.Also, the sheath tip id was noted to be slightly wider.Next, the sheath failed the boroscope testing, as a liner damage was revealed along sheath lumen; light markings/lines of sheath damage first appeared close to a quarter-way through the sheath lumen and continued towards the hub, and became more prominent towards the hub, indicating the source was closer to the proximal end.An additional strand appeared to be bunched closer to the hub, indicating resistance was encountered during the onset of the damage.The reported allegation is confirmed through media and testing as the sheath has been returned to bsc for analysis.There is no evidence to suggest that the bsc product did not meet specifications prior to use.Additionally, a correction on first supplemental report was done on the field initial reporter email (e1), in section e - initial reporter.

• Brand Name: VERSACROSS STEERABLE ACCESS SOLUTION
• Common Device Name: INTRODUCER, CATHETER
• 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: 20291710
• Report Number: 2124215-2024-59486
• Device Sequence Number: 12793946
• Product Code: DYB
• UDI-Device Identifier: 00685447012078
• UDI-Public: 00685447012078
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K190688
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/26/2025

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: 0034257628
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2024
• Supplement Date Received by Manufacturer: 10/24/2024; 03/20/2025
• Initial Report FDA Received Date: 09/24/2024
• Supplement Report FDA Received Date: 10/30/2024; 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown