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

Model Number TF85-32-63-45

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Tamponade (2226)

Event Date 01/04/2019

Event Type  Injury  

Manufacturer Narrative

Review of the device history record for the lot in question confirmed that all parts met manufacturing requirements prior to release.There is no suspected device failure.The reported patient complication is an inherent risk in this type of procedure.

Event Description

The torflex transseptal guiding sheath was used in a procedure.A patent foramen ovale (pfo) was observed during transesophageal echocardiography (tee) prior to the procedure.The physician wanted to cross the septum through the pfo.The physician used the torflex sheath with a st.Jude grid to cross the pfo but soon after mapping started, lost axis.The physician rewired into the superior vena cava (svc) and put in the dilator.Once dropping onto the septum, the torflex sheath and dilator crossed into the septum.About two minutes later, the patient's blood pressure dropped.Tee was performed and tamponade was observed.Heparin was reversed and pericardiocentesis was performed.

• Brand Name: TORFLEX TRANSSEPTAL GUIDING SHEATH
• Type of Device: CATHETER INTRODUCER
• Manufacturer (Section D): BAYLIS MEDICAL COMPANY INC.; 5959 trans-canada highway; montreal, quebec H4T 1 A1; CA H4T 1A1
• Manufacturer (Section G): BAYLIS MEDICAL COMPANY INC.; 2775 matheson blvd. east; mississauga, ontario L4W 4 P7; CA L4W 4P7
• Manufacturer Contact: meghal khakhar ; 2775 matheson blvd. east; mississauga, ontario L4W 4-P7 ; CA L4W 4P7
• MDR Report Key: 8289711
• MDR Text Key: 134502659
• Report Number: 9710452-2019-00003
• Device Sequence Number: 1
• Product Code: DYB
• 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: 01/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2021
• Device Model Number: TF85-32-63-45
• Device Lot Number: TFFC241018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention