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

Lot Number	SSFC061223
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2024
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 an atrial fibrillation (a fib) ablation procedure, a sureflex steerable guiding sheath was selected for use.During preparation, the medical engineer noted there was a crack on the sheath after unpacking it.The procedure was completed using another same of device.No patient complications occurred.The device is expected to be returned for analysis.No other issues were noted.
Additional Manufacturer Narrative
The sureflex steerable sheath and dilator were returned for analysis.This supplemental mdr is being field.Analysis of the device during pre-decontamination visual inspection and testing confirmed the rotating knob worked properly for both sides, flushing was successful and no visible damages on tips or valves.Upon post-decontamination visual inspection and testing it was confirmed there were no damage, cracks, no issues found with rotation of the steering mechanism, and the sureflex cap handle and hub cap both remained attached to their respective bodies.The device passed the curve overlay test.Thus, the reported allegation was not confirmed.Additionally, the field g4 (premarket / 510(k) #) was updated.
Event or Problem Description
It was reported that during an atrial fibrillation (a fib) ablation procedure, a sureflex steerable guiding sheath was selected for use.During preparation, the medical engineer noted there was a crack on the sheath after unpacking it.The procedure was completed using another same of device.No patient complications occurred.The device is expected to be returned for analysis.No other issues were noted.

• 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: 19127043
• Report Number: 2124215-2024-23229
• Device Sequence Number: 12823972
• 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): 06/14/2024

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 Expiration Date: 07/12/2025
• Device Lot Number: SSFC061223
• 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: 04/01/2024
• Supplement Date Received by Manufacturer: 05/28/2024
• Initial Report FDA Received Date: 04/17/2024
• Supplement Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2023
• 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): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown