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

Lot Number	0034329678
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that during a cardiac ablation procedure to treat atrial fibrillation (a fib), a versacross access solution kit was selected for use.Prior to opening the device, it was noted that device packaging had a small rip in it.The devices did not seemed to be damaged however it was only a sterilization issue.Hence, the device was replaced and the procedure was completed successfully.No patient complications occurred.The device is not expected to be returned for analysis.
Additional Manufacturer Narrative
The device was not returned, however, the reported allegation of a small rip in the package was confirmed through media provided.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 cardiac ablation procedure to treat atrial fibrillation (a fib), a versacross access solution kit was selected for use.Prior to opening the device, it was noted that device packaging had a small rip in it.The devices did not seemed to be damaged however it was only a sterilization issue.Hence, the device was replaced and the procedure was completed successfully.No patient complications occurred.The device is not expected to be returned for analysis.

• Brand Name: VERSACROSS ACCESS SOLUTION
• Common Device Name: CATHETER, SEPTOSTOMY
• 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: 20523346
• Report Number: 2124215-2024-66446
• Device Sequence Number: 9117593
• Product Code: DXF
• UDI-Device Identifier: 00685447011859
• UDI-Public: 00685447011859
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2024

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: Other
• Device Lot Number: 0034329678
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2024
• Supplement Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 10/24/2024
• Supplement Report FDA Received Date: 11/15/2024
• Date Device Manufactured: 03/21/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown