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

Lot Number	TFFB060323
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2023
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 the preparation of the transeptal puncture procedure to treat atrial fibrillation, torflex transseptal guiding sheath was selected for use.The broken device was noted upon opening the package no troubleshooting steps have been mentioned.The procedure was completed successfully by using another torflex transseptal guiding sheath.No patient complications have been reported.The product is expected to be returned.No further issues have been reported.
Additional Manufacturer Narrative
This is supplemental mdr to report investigation results.The returned torflex transseptal guiding sheath was analyzed, and a visual inspection result noted that there were no visual defects on dilator and sheath.The returned product passed the pre-decon flushing and the post-decon flushing test.The stopcock handle was returned in a separate pouch.The vhx testing of the stopcock confirmed the break at the neck of the lever of the sheath.There was resistance noted during the stopcock rotation while performing the manual manipulation testing.
Event or Problem Description
It was reported that during the preparation of the transeptal puncture procedure to treat atrial fibrillation, torflex transseptal guiding sheath was selected for use.The broken device was noted upon opening the package.No troubleshooting steps have been mentioned.The procedure was completed successfully by using another torflex transseptal guiding sheath.No patient complications have been reported.The product is expected to be returned.No further issues have been reported.

• Brand Name: TORFLEX TRANSSEPTAL 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: 17981299
• Report Number: 2124215-2023-55479
• Device Sequence Number: 3518361
• Product Code: DYB
• UDI-Device Identifier: 00685447005391
• UDI-Public: 00685447005391
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K183655
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2024

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: 03/02/2024
• Device Lot Number: TFFB060323
• 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: 09/21/2023
• Supplement Date Received by Manufacturer: 01/25/2024
• Initial Report FDA Received Date: 10/20/2023
• Supplement Report FDA Received Date: 02/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown