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

Lot Number	SSFB060123
Medical Device Problem Codes	Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2023
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 that during a catheter ablation procedure to treat paroxysmal epigastric tachycardia, a sureflex steerable guiding sheath was selected for use.During insertion to draw reverse blood, air was noted at the hemostasis valve part of the sheath.The sheath was then flushed and re-inserted.Air was pulled out the same way.Therefore, to resolve the issue, the device was replaced, and the procedure was completed successfully.No patient complications occurred.The device is expected to be returned for analysis.
Event or Problem Description
It was reported that during a catheter ablation procedure to treat paroxysmal epigastric tachycardia, a sureflex steerable guiding sheath was selected for use.During insertion to draw reverse blood, air was noted.The sheath was then flushed and re-inserted.Air was pulled out the same way.Therefore, to resolve the issue, the device was replaced, and the procedure was completed successfully.No patient complications occurred.The device is expected to be returned for analysis.
Additional Manufacturer Narrative
Correction to the mdr in block h8 usage of device supplemental mdr is being submitted to report investigation results.Mdr aware date 04dec2023.The device was returned for analysis.The pre-decontamination was conducted and confirmed there were no visible damages, the rotation of the device was functional and flushing was successful.The vhx imaging test on both sheath and dilator identified a bend at the dilator hub as well as a potential tear in the sheath valve.The air and leakage test were performed and confirmed there were no signs of either form of leakage detected in any of the four test states.Hence, the reported allegation could not be confirmed.

• 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: 17625865
• Report Number: 2124215-2023-45124
• Device Sequence Number: 7302132
• Product Code: DYB
• UDI-Device Identifier: 00685447006213
• UDI-Public: 00685447006213
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K122926
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2023

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 Lot Number: SSFB060123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/02/2023
• Supplement Date Received by Manufacturer: 12/04/2023
• Initial Report FDA Received Date: 08/25/2023
• Supplement Report FDA Received Date: 12/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown