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

Model Number	TSK85-32-BD-71S
Medical Device Problem Codes	Difficult to Insert (1316); Defective Device (2588)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/26/2023
Type of Reportable Event	Serious Injury
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 percutaneous catheter myocardial ablation procedure to treat atrial fibrillation (a fib) in right inguinal area, a sureflex steerable guiding sheath was selected for use.When the sureflex was tried to be inserted, the tip of the sheath got lifted and the bleeding continued from the side of the sheath.This occurred just below the right inguinal region.It was not advanced deep in the anatomy.There was slight difficulty removing the sheath.The bleeding was stopped with a non-boston scientific device.A new sureflex was used to perform a new puncture.The procedure was completed successfully, and no patient complications occurred.The device is expected to be returned for analysis.
Additional Manufacturer Narrative
The device was returned for analysis.Analysis of the device found the complaint could not be recreated on a top-bench model; therefore, the potential root cause of the complaint cannot be conclusively determined.From the information provided in the complaint summary and testing on the returned product, it is highly unlikely that the sheath left our facility with sheath tip damage since all sheaths undergo 100 percentage visual inspection.The most likely root cause is excessive force applied to patient anatomy by device.There is no evidence to suggest the device did not meet specifications as per testing.The reported allegation is confirmed since the sheath was shown to be deformed through returned product and media.Based on the root cause of the complaint, the failure to follow instructions code was selected.The ifu states do not use excessive force to advance or withdraw the device in dhf tss 5.1a.In addition, the sheath tip was shown to meet specifications.
Event or Problem Description
It was reported that during a percutaneous catheter myocardial ablation procedure to treat atrial fibrillation (a fib) in right inguinal area, a sureflex steerable guiding sheath was selected for use.When the sureflex was tried to be inserted, the tip of the sheath got lifted and the bleeding continued from the side of the sheath.This occurred just below the right inguinal region.It was not advanced deep in the anatomy.There was slight difficulty removing the sheath.The bleeding was stopped with a non-boston scientific device.A new sureflex was used to perform a new puncture.The procedure was completed successfully, and no patient complications occurred.The device is expected to be returned for analysis.

• Brand Name: SUREFLEX STEERABLE GUIDING SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): BAYLIS MEDICAL COMPANY INC.; 5959 trans-canada highway; montreal, qc 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: 17344138
• Report Number: 2124215-2023-37488
• Device Sequence Number: 20464045
• Product Code: DYB
• UDI-Device Identifier: 00685447006305
• UDI-Public: 00685447006305
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/02/2024
• Device Model Number: TSK85-32-BD-71S
• Device Lot Number: SSFB150922
• 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: 06/26/2023
• Supplement Date Received by Manufacturer: 10/03/2023
• Initial Report FDA Received Date: 07/18/2023
• Supplement Report FDA Received Date: 10/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2022
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 55 KG