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

Lot Number	0034735671
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2024
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 during a pulmonary vein isolation ablation procedure, a versacross access solution kit was selected for use.The versacross sheath was taken out of package sterile and flushed.It was then advanced inside the patient (right atrium) and crossed into left atrium where it was noted to have a "clot" like image on the intracardiac echocardiography (ice) catheter.The activated clotting time (act) at this time was greater than 410 seconds.The physician went into emergency planning to remove the "clot" and safely removed the sheath.Once the sheath was outside of the patient, it was flushed with saline to find no clots present.However, there was a long string of "plastic substance" that had come from the sheath.The physician feels that the "clot like substance" on the ice catheter was the "plastic string-like" particle.Hence, the device was replaced with versacross connect kit and the procedure was completed successfully.No patient complications occurred.The device is expected to be returned for analysis.
Additional Manufacturer Narrative
Due to additional information received, the field b5 (describe event or problem) was updated.The device has been received for analysis.Upon 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 during a pulmonary vein isolation ablation procedure, a versacross access solution kit was selected for use.The versacross sheath was taken out of package sterile and flushed.It was then advanced inside the patient (right atrium) and crossed into left atrium where it was noted to have a "clot" like image on the intracardiac echocardiography (ice) catheter.The activated clotting time (act) at this time was greater than 410 seconds.The physician went into emergency planning to remove the "clot" and safely removed the sheath.Once the sheath was outside of the patient, it was flushed with saline to find no clots present.However, there was a long string of "plastic substance" that had come from the sheath.The physician feels that the "clot like substance" on the ice catheter was the "plastic string-like" particle.Hence, the device was replaced with versacross connect kit and the procedure was completed successfully.No patient complications occurred.The device is expected to be returned for analysis.Uf/importer report # (b)(4).It was further confirmed there was no damage to the sheath or packaging.The issue was identified after transseptal access had been obtained and in the left atrium.The non-boston scientific pentaray mapping catheter (bsw) had been inserted and was the only device that was inserted into the versacross sheath which could have potentially caused skiving or the string could have come from the pentaray.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, the versacross sheath was visually inspected, and a sheath liner torn was noted, extending to distal tip.Also, a minor bunch was noted at sheath tip.The fiber had one edge bunched and one edge that appeared cut and a slight bunching on outside of sheath tip was also noted.During testing, cutting open sheath tip revealed that tear extended all the way to its distal tip.The reported allegation was confirmed.
Event or Problem Description
It was reported during a pulmonary vein isolation ablation procedure, a versacross access solution kit was selected for use.The versacross sheath was taken out of package sterile and flushed.It was then advanced inside the patient (right atrium) and crossed into left atrium where it was noted to have a "clot" like image on the intracardiac echocardiography (ice) catheter.The activated clotting time (act) at this time was greater than 410 seconds.The physician went into emergency planning to remove the "clot" and safely removed the sheath.Once the sheath was outside of the patient, it was flushed with saline to find no clots present.However, there was a long string of "plastic substance" that had come from the sheath.The physician feels that the "clot like substance" on the ice catheter was the "plastic string-like" particle.Hence, the device was replaced with versacross connect kit and the procedure was completed successfully.No patient complications occurred.The device is expected to be returned for analysis.Uf/importer report # (b)(4).It was further confirmed there was no damage to the sheath or packaging.The issue was identified after transseptal access had been obtained and in the left atrium.The non-boston scientific pentaray mapping catheter (bsw) had been inserted and was the only device that was inserted into the versacross sheath which could have potentially caused skiving or the string could have come from the pentaray.

• Brand Name: VERSACROSS 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; zona franca la lima; cartgo, 03 30106 ; CS 30106
• Manufacturer Contact: angela hinkley ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 20560117
• Report Number: 2124215-2024-67804
• Device Sequence Number: 11541840
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/28/2025

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: 0034735671
• 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: 10/09/2024
• Supplement Date Received by Manufacturer: 11/07/2024; 01/11/2025
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 11/19/2024; 01/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 70 KG
• Patient Race: Black Or African American