MAUDE Adverse Event Report: BIOSENSE WEBSTER INC CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - SMALL; INTRODUCER, CATHETER

Model Number D138501

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 04/15/2022

Event Type  Injury  

Event Description

It was reported that a (b)(6) female patient underwent an atrial fibrillation (afib) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath - small.The patient suffered cardiac tamponade requiring pericardiocentesis, surgical intervention, and prolonged hospitalization.It was reported that during the procedure, a perforation was discovered.There was an immediate drop in blood pressure on the patient when the perforation occurred.The perforation was confirmed by intracardiac echocardiography (ice).The medical intervention provided was a pericardiocentesis and it was unknown how much fluid was removed.The patient had to be taken into surgery and when the event was called in was still in surgery.The patient¿s status was currently unknown.The physician believed the perforation occurred when the carto vizigo¿ 8.5f bi-directional guiding sheath - small dilator was being used to get the sheath across the septum after going transseptal and the dilator was inserted too far which perforated the left atrial appendage.Additional information was received on the event.Physician did not state his opinion on what caused the adverse event but did not mention it being a bwi product malfunction.Patient outcome is unknown after surviving open heart surgery.The patient required extended hospitalization due to open heart surgery and requirement of leaving the sternum open for two days prior to closure.Other relevant history includes: two prior afib ablations last one being in 2018.Ablation catheter not used for procedure.

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: CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - SMALL
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (IRVINE); 33 technology drive; irvine CA 92618
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14349612
• MDR Text Key: 291949354
• Report Number: 2029046-2022-00995
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835016253
• UDI-Public: 10846835016253
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D138501
• Device Catalogue Number: D138501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2022
• 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: SMARTABLATE GENERATOR KIT-US
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening
• Patient Age: 72 YR
• Patient Sex: Female