MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY INC. SUREFLEX STEERABLE GUIDING SHEATH; INTRODUCER, CATHETER

Model Number	TSK85-32-BD-71M
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an ablation procedure to treat atrial fibrillation (afib), a sureflex steerable sheath was selected for use.During the procedure a leak was noted in the sheath.The sheath was replaced, and the procedure was completed without any patient complications.The product will be returned for laboratory 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
Correction to d1: brand name from versacross access solution to sureflex steerable guiding sheath.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 that during an ablation procedure to treat atrial fibrillation (afib), a sureflex steerable sheath was selected for use.During the procedure a leak was noted in the sheath.The sheath was replaced, and the procedure was completed without any patient complications.The product will be returned for laboratory analysis.
Additional Manufacturer Narrative
Correction to g2: report source from company representative, foreign, health professional to foreign, health professional, user facility.The sureflex steerable guiding sheath was received for analysis.Upon receipt at our post market quality assurance laboratory the sheath underwent a visual inspection, vhx testing, and leakage testing.No defects were noted from the visual inspection.The vhx test revealed dried blood on the outside of the valve as well as tearing under magnification.Leakage testing, consisting of the hemostasis valve air and liquid leakage tests, was performed without signs of liquid or air leakage from the sheath or valve.Laboratory analysis confirmed the reported clinical observations.
Event or Problem Description
It was reported that during an ablation procedure to treat atrial fibrillation (afib), a sureflex steerable sheath was selected for use.During the procedure a leak was noted in the sheath.The sheath was replaced, and the procedure was completed without any patient complications.The product is available for return.

• Brand Name: SUREFLEX STEERABLE GUIDING SHEATH
• 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): BAYLIS MEDICAL COMPANY INC.; 5825 explorer drive; mississauga on L4W 5 P6; CA L4W 5P6
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 16636685
• Report Number: 2124215-2023-13849
• Device Sequence Number: 7234540
• Product Code: DYB
• UDI-Device Identifier: 00685447006312
• UDI-Public: 00685447006312
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/23/2023

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: 03/02/2024
• Device Model Number: TSK85-32-BD-71M
• Device Lot Number: SSFC290522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/02/2023
• Supplement Date Received by Manufacturer: 05/02/2023; 05/29/2023
• Initial Report FDA Received Date: 03/29/2023
• Supplement Report FDA Received Date: 05/04/2023; 06/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Sex: Female