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

Lot Number	0034515016
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 that a versacross large access solution kit was selected for atrial fibrillation (a fib) ablation.Prior to the procedure, during preparation, it was mentioned that when the sterile packaging for the kit was opened, a loose long black hair was observed to be inside the sterile packaging.Thus, the device was replaced, and the procedure was completed 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 large access solution kit was selected for atrial fibrillation (a fib) ablation.Prior to the procedure, during preparation, it was mentioned that when the sterile packaging for the kit was opened, a loose long black hair was observed to be inside the sterile packaging.Thus, the device was replaced, and the procedure was completed successfully.No patient complications were reported.The device is expected to be returned for analysis.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, the versacross rf wire was visually inspected and it passed; the sterile seal was found opened and did not find hair.Based on the information provided in the complaint's summary and returned product investigation results, the reported allegation cannot be confirmed as the hair was not returned and no media was provided.

• Brand Name: VERSACROSS LARGE 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; 2775 matheson blvd east; mississauga, on L4W 4 P7; CA L4W 4P7
• Manufacturer Contact: angela hinkley ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 20207941
• Report Number: 2124215-2024-57127
• Device Sequence Number: 15396016
• Product Code: DXF
• UDI-Device Identifier: 00685447012535
• UDI-Public: 00685447012535
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2024

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 Lot Number: 0034515016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2024
• Supplement Date Received by Manufacturer: 10/19/2024
• Initial Report FDA Received Date: 09/12/2024
• Supplement Report FDA Received Date: 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown