MAUDE Adverse Event Report: BIOSENSE WEBSTER INC WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY; ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE

Model Number BD710DF282RTS

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 11/20/2020

Event Type  Injury  

Manufacturer Narrative

The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturer record evaluation cannot be conducted because the no lot number was provided by the customer.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent a cryo ablation procedure for atrial fibrillation (afib) and suffered cardiac tamponade requiring pericardiocentesis and surgical intervention.During the procedure, a webster ® cs catheter with ez steer¿ technology was placed in the coronary sinus (cs) and was noted to be vertical; however, good electrical signals were observed.Procedure was completed, and all catheters were removed from the patient¿s body.Post-procedure, the patient¿s blood pressure became unstable, and the patient did not feel well.Echocardiography showed pericardial effusion.Pericardiocentesis was performed to drain the pericardial space; however, the effusion did not stop.The patient was moved to the operation room and a sternotomy was performed to check for perforations of the left atrium to determine the tamponade site.No visual perforations were noted; however, the cavity continued to fill.Discussion with electrophysiologist who asked surgeons to physically lift heart out to look anterior.Fat patch over area lifted, and perforation of the cs found, the distal cs catheter had perforated cs during initial insertion.The perforation was surgically repaired.Patient¿s condition had improved.Prolonged hospitalization of about 5-6 days was required plus additional rehab.Physician¿s opinion regarding the cause of the adverse event is that it was procedure related.No bwi ablation catheter was used.Since this event is life threatening and required intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr-reportable.

• Brand Name: WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY
• Type of Device: ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 11062353
• MDR Text Key: 224383829
• Report Number: 2029046-2020-01980
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835002416
• UDI-Public: 10846835002416
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K090898
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BD710DF282RTS
• Device Catalogue Number: BD710DF282RTS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/01/2020
• Initial Date FDA Received: 12/23/2020
• 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: Initial
• Patient Sequence Number: 1