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

Lot Number	SSFA290921
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not yet 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 will be filed.
Event or Problem Description
It has been reported that a sureflex steerable guiding sheath was selected for use for an unknown procedure.It has been mentioned that the user experienced an issue where the sheath was exposed to foreign material.No patient complications reported.Device and procedure outcome are unknown.Product is expected to return for analysis.
Event or Problem Description
It has been reported that a sureflex steerable guiding sheath was selected for use for an unknown procedure.It has been mentioned that the user experienced an issue where the sheath was exposed to foreign material.No patient complications reported.Device and procedure outcome are unknown.Product is expected to return for analysis.
Additional Manufacturer Narrative
The device has been returned for analysis.Analysis of the device found that the original packaging was opened but the sterile seal was left intact.Further, an embedded black spot, 0.25 mm^2 in size, was located inside the plastic tray towards the distal tip of the device.The tray was taken for a closer inspection and the foreign material was found to be embedded within the plastic tray and could not be loosened.However, the size of the particle does not meet bsc acceptance criteria for loose particulate (0 instances of contamination >0.20 mm^2 in size are permitted) and is therefore considered a failure.A tappi chart was used to measure the foreign matter and failed the specification for maximum allowable particulate size.

• 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: 17813657
• Report Number: 2124215-2023-50356
• Device Sequence Number: 15126262
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2024

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: Other
• Device Expiration Date: 03/02/2024
• Device Lot Number: SSFA290921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2023
• Supplement Date Received by Manufacturer: 01/19/2024
• Initial Report FDA Received Date: 09/25/2023
• Supplement Report FDA Received Date: 02/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown