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

Medical Device Problem Code	Flushing Problem (1252)
Health Effect - Clinical Code	Transient Ischemic Attack (2109)
Date of Event	11/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.
Event or Problem Description
It was reported the patient strokes occurred.During an ablation procedure, a sureflex steerable guiding sheath was selected for use.The sheath was prepared and then introduced into the left atrium.The sheath was aspirated to prevent bubbles.Once the device were connected with a non-boston scientific mapping catheter and ablating device, ablation was performed and the catheter was pulled out from the sheath.At this point when the physician tried to aspirate, a resistance was felt.The physician immediately stopped the procedure and pulled the sheath out.Outside the patient body, the sheath was flushed but there was no blood coagulum.The device is not expected to be returned for analysis.The sheath was flushed/aspirated without anything in it, it was after getting the ablation catheter out of the sheath it couldn't be aspirated.No damages or issues noted with the stopcock.After getting the sheath out there were nothing on the tip.The "little strokes" were slowly transient and the patient seem to be recover.

• 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: 18325795
• Report Number: 2124215-2023-70083
• Device Sequence Number: 6951745
• Product Code: DYB
• UDI-Device Identifier: 00685447006312
• UDI-Public: 00685447006312
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/14/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/21/2023
• Initial Report FDA Received Date: 12/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown