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

Device Problem Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/02/2024

Event Type  malfunction  

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 Description

It was reported that a bmc transseptal sheath (torflex) was selected for use.The physician has comment it is difficult to cross the septum during a transeptal procedure.It is harder to get the sheath and dilator across the septum after puncture.This issue had happened couple of times in the last few months.No unusual anatomy or resistance was noted.No patient complications were reported.The procedure was completed successfully.The device is not expected to be returned for analysis (disposed).

• Brand Name: TORFLEX TRANSSEPTAL GUIDING SHEATH
• Type of Device: 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: 18565678
• MDR Text Key: 333506172
• Report Number: 2124215-2024-00430
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00685447000648
• UDI-Public: 00685447000648
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183655
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/23/2024

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/02/2024
• Initial Date FDA Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1