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

Lot Number	VXF060723A
Medical Device Problem Codes	Material Split, Cut or Torn (4008); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received at boston scientific where it is awaiting analysis.Upon completion of the failure analysis of the complaint device a supplemental medwatch will be filed.
Event or Problem Description
It has been reported that a versacross access solution kit has been selected for use for an atrial fibrillation (a fib) ablation procedure.During the procedure, the physician mentioned that the sheath had a string-like filament in it when it was pulled out of the body.The physician also reported experiencing friction as they advanced the dilator over the wire.They also were not sure if it was the non-boston scientific pentaray device scratching as well.No patient complications reported.Product is expected to return for analysis.The procedure was completed successfully.
Additional Manufacturer Narrative
The device was returned for analysis.Visual inspection of the device exterior confirmed no anomalies with the dilator, sheath or the stopcock.Additionally, flushing of the device was successful.Analytical testing was also performed.The borescope testing identified damage to the versacross access solution sheath liner between the distal and proximal ends (15 cm from the tip).The liner tear appears to be thickest at the distal end and tapers off at the proximal end.The returned versacross access solution sheath liner was also inspected under a vhx digital microscope, which revealed a clean break at the thin end (proximal) and a rough break at the thick end (distal).The sheath tip was also cut open and inspected under vhx digital microscope, confirming that the end of the liner tear is at the distal end of the platinum iridium band and revealed minor delamination at the distal tip.During friction testing, a small amount of resistance was encountered when backloading the versacross access solution dilator onto the rf wire.However, this was within the normal/expected range of friction.
Event or Problem Description
It has been reported that a versacross access solution kit has been selected for use for an atrial fibrillation (a fib) ablation procedure.During the procedure, the physician mentioned that the sheath had a string-like filament in it when it was pulled out of the body.They also reported experiencing friction as they advanced the dilator over the wire and they were not sure if it was the non-boston scientific pentaray device scratching as well.The procedure was completed successfully using the same kit as the issue was noted at the end of the procedure.No damage was noted upon removal from the packaging.No patient complications reported.Product is expected to return for analysis.02nov2023: gfe response received - it has been further mentioned that the procedure was completed successfully with the same kit as the issue was noted at the end of the procedure.There was no damage noted to the upon removal from the packaging.
Additional Manufacturer Narrative
Due to additional information received from medwatch report on 20may2024, the fields a2 (age at time of event and unit of measure - age), b5 (describe event or problem), e4 (init rptr also sent rep to fda) and g2 (report source and report source (other)) were updated.Thus, this supplemental mdr is being submitted.
Event or Problem Description
It has been reported that a versacross access solution kit has been selected for use for an atrial fibrillation (a fib) ablation procedure.During the procedure, the physician mentioned that the sheath had a string-like filament in it when it was pulled out of the body.They also reported experiencing friction as they advanced the dilator over the wire and they were not sure if it was the non-boston scientific pentaray device scratching as well.The procedure was completed successfully using the same kit as the issue was noted at the end of the procedure.No damage was noted upon removal from the packaging.No patient complications reported.Product is expected to return for analysis.02nov2023: gfe response received - it has been further mentioned that the procedure was completed successfully with the same kit as the issue was noted at the end of the procedure.There was no damage noted to the upon removal from the packaging.It was further received a medwatch report # (b)(4).The physician completed the case and pulled the non-boston scientific octaray mapping catheter out of versacross sheath and noticed a filament nylon appearing thread wrapped around the octaray.The device did not do what was supposed to do.
Event or Problem Description
It has been reported that a versacross access solution kit has been selected for use for an atrial fibrillation (a fib) ablation procedure.During the procedure, the physician mentioned that the sheath had a string-like filament in it when it was pulled out of the body.They also reported experiencing friction as they advanced the dilator over the wire and they were not sure if it was the non-boston scientific pentaray device scratching as well.The procedure was completed successfully using the same kit as the issue was noted at the end of the procedure.No damage was noted upon removal from the packaging.No patient complications reported.Product is expected to return for analysis.On 02nov2023: gfe response received - it has been further mentioned that the procedure was completed successfully with the same kit as the issue was noted at the end of the procedure.There was no damage noted to the upon removal from the packaging.It was further received a medwatch report #(b)(4).The physician completed the case and pulled the non-boston scientific octaray mapping catheter out of versacross sheath and noticed a filament nylon appearing thread wrapped around the octaray.The device did not do what was supposed to do.
Additional Manufacturer Narrative
Correction to the follow-up 2: the field h10 (related report number (1)) was updated.Thus, this supplemental mdr is being submitted.

• Brand Name: VERSACROSS ACCESS SOLUTION
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): BAYLIS MEDICAL COMPANY INC.; 5959 trans-canada highway; montreal H4T 1 A1; CA H4T 1A1
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA SRL; la lima business park; la lima, 03 ; CS
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 18070008
• Report Number: 2124215-2023-61346
• Device Sequence Number: 12678985
• Product Code: DYB
• UDI-Device Identifier: 00685447011736
• UDI-Public: 00685447011736
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K183655
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/24/2024

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 Expiration Date: 01/19/2025
• Device Lot Number: VXF060723A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/11/2023
• Supplement Date Received by Manufacturer: 12/12/2023; 05/20/2024; 06/17/2024
• Initial Report FDA Received Date: 11/03/2023
• Supplement Report FDA Received Date: 01/08/2024; 06/11/2024; 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Sex: Unknown