MAUDE Adverse Event Report: BAYLIS MEDICALE CIE INC SUREFLEX STEERABLE GUIDING SHEATH; INTRODUCER, CATHETER

Lot Number	0034302013
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2024
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 during a procedure, a sureflex steerable guiding sheath was selected for use.The dilator was found to have a small piece hanging at the distal tip.The defect was found when the sheath was being flushed.Hence the device was replaced.No patient complications occurred.The device is expected to be returned for analysis.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, visual inspection of the device noted that its tip was clogged, the flushing was not smooth.No other damage was revealed.Functional testing was performed, and a material was observed in the tip of the dilator, appearing to match its color.The majority of material was able to be removed from tip with tweezers, although final section could not be removed.After, flushing was conducted, and it was successful.Next, the inside diameter of the device was noted to be within specification.Also, a slight kink was observed at shaft-handle connection.Finally, no issue was noted tracking a 0.032 guidewire through the dilator; a 0.035 guidewire was passed through a sample dilator with resistance, but unable to recreate the damage; and it was possible to pass a sample dilator through sheath without difficulty or damage.With all the available information, the reported allegation of a damaged tip was confirmed based on the returned device.
Event or Problem Description
It was reported during a procedure, a sureflex steerable guiding sheath was selected for use.The dilator was found to have a small piece hanging at the distal tip.The defect was found when the sheath was being flushed.Hence the device was replaced.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 MEDICALE CIE INC; 5959 trans-canada highway; montreal H4T 1 A1; CA H4T 1A1
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2775 matheson blvd east; mississauga, on L4W 4 P7; CA L4W 4P7
• Manufacturer Contact: angela hinkley ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 20515333
• Report Number: 2124215-2024-66119
• Device Sequence Number: 12523813
• Product Code: DYB
• UDI-Device Identifier: 00685447006305
• UDI-Public: 00685447006305
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 01/09/2025

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: 07/20/2026
• Device Lot Number: 0034302013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2024
• Supplement Date Received by Manufacturer: 12/21/2024
• Initial Report FDA Received Date: 10/23/2024
• Supplement Report FDA Received Date: 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown