MAUDE Adverse Event Report: BIOSENSE WEBSTER INC DECANAV ELECTROPHYSIOLOGY CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number R7F282CT

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Cardiac Tamponade (2226); Unspecified Tissue Injury (4559)

Event Date 06/22/2022

Event Type  Injury  

Event Description

It was reported that a 74-year-old female patient underwent an atrial fibrillation (afib) ablation procedure with a decanav electrophysiology catheter.The patient suffered cardiac tamponade requiring pericardiocentesis and prolonged hospitalization.It was reported that the patient had a pericardial effusion, this was confirmed during baseline imaging with the soundstar catheter before getting transeptal access.A pericardiocentesis was done and 350ml of fluid was removed.The patient's blood pressure did drop but after the pericardiocentesis, the blood pressure recovered.The physician thinks the issue may have occurred when they were trying to disconnect the decanav electrophysiology catheter from the carto 3 system, the catheter moved from the coronary sinus (cs) into the right ventricular outflow tract (rvot) when they reconnected the catheter to the patient interface unit (piu).The case continued and was completed.The patient stayed overnight for observation.The caller also states that while giving isoprenyl during the ep study, the intra-aortic blood pressure rose to 220/180 and then increased with the isoprenyl was given.Once the isoprenyl was titrated down and stopped the intra-aortic blood pressure normalized.Additional information was received on the event.No radio frequency catheters were introduced in the body.Decanav electrophysiology catheter was used as mapping catheter.The adverse event was discovered during use of biosense webster products during ep study/diagnostic phase.The physician¿s opinion on the cause of this adverse event was that it was procedure related.The patient outcome of the adverse event was improved.The patient required extended hospitalization because of the adverse event.The physician stated that he found some tissue at the tip of decanav electrophysiology catheter.He sent it for histology evaluation to determine type of tissue.A transseptal puncture was not performed, the effusion found prior to transseptal puncture, during baseline imaging with soundstar catheter.No ablation was performed.The generator information is a smartablate generator kit-us which was not used during the procedure.Soft tissue injury was added for ¿the physician stated that he found some tissue at the tip of decanav.He sent it for histology evaluation to determine type of tissue.¿ should more information become available, it will be reviewed and processed accordingly.

Manufacturer Narrative

The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because 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).

• Brand Name: DECANAV ELECTROPHYSIOLOGY CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez ; MX
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15033302
• MDR Text Key: 296045144
• Report Number: 2029046-2022-01630
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835008807
• UDI-Public: 10846835008807
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080425
• 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: 07/15/2022

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: R7F282CT
• Device Catalogue Number: R7F282CT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/22/2022
• Initial Date FDA Received: 07/15/2022
• 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
• Treatment: NON BWI ¿ ABBOTT QUAD POLAR CATHETER; NON BWI ¿ ABBOTT QUAD POLAR CATHETER; NON BWI ¿ ABBOTT QUAD POLAR CATHETER; SMARTABLATE GENERATOR KIT-US; UNK_CARTO 3; UNK_SOUNDSTAR
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening
• Patient Age: 74 YR
• Patient Sex: Female