MAUDE Adverse Event Report: BAYLIS MEDICAL CO., INC. TORFLEX TRANSSEPTAL GUIDING SHEATH; SHEATH, DILATOR, GUIDEWIRE

Model Number TF85-32-63-45

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/12/2015

Event Type  malfunction  

Event Description

The torflex transseptal guiding sheath was being used in a procedure when the physician observed some material near the valve of the sheath.The material was removed by the physician and the procedure was continued.

Manufacturer Narrative

The returned device investigation is currently in progress.If any additional relevant information is identified following completion of the device investigation, the additional relevant information will be submitted in a follow-up report.Information from this incident will be included in our product complaint trend reporting system.Ongoing analysis of trend information will be used to identify the need for additional investigations.

• Brand Name: TORFLEX TRANSSEPTAL GUIDING SHEATH
• Type of Device: SHEATH, DILATOR, GUIDEWIRE
• Manufacturer (Section D): BAYLIS MEDICAL CO., INC.; 5959 trans-canada highway; montreal, quebec H4T 1 A1; CA H4T 1A1
• Manufacturer Contact: meghal khakhar ; 2645 matheson blvd. e; mississauga, ontario L4W 5-S4 ; CA L4W 5S4 ; 9056024875
• MDR Report Key: 4611689
• MDR Text Key: 16545695
• Report Number: 9710452-2015-00003
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102948
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2015
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2016
• Device Model Number: TF85-32-63-45
• Device Catalogue Number: TF85-32-63-45
• Device Lot Number: TFFA220813
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1