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 Arrest (1762)

Event Date 05/10/2022

Event Type  Injury  

Event Description

It was reported that a (b)(6) male patient underwent an atrial flutter right (r-afl) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath - small.The patient suffered cardiac arrest requiring cpr.It was reported that at the beginning of a right-sided atrial flutter procedure, asystole was noticed in the patient.After the patient was put under anesthesia, the anesthesiologist noticed that the patient's blood pressure dropped.The patient went into asystole, and "turned blue." there were no r waves present on the recording system or the anesthesia monitor.The physician had access with the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ small at this point in the procedure, but no catheters had been introduced to the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ small.A code was called for the patient.The medical intervention provided was to resuscitate the patient, and cardiopulmonary resuscitation (cpr) was performed.The procedure was aborted.The patient was reported to be in stable condition, and the patient was transferred to the intensive care unit.The physician noticed prior to the procedure, when performing a transesophageal echocardiogram (tee), that the patient had an "enormous" right atrium.The physician believes the cause of the issue may be due to undiagnosed pulmonary hypertension.Additional information was received on the event.This adverse event was discovered during use of biosense webster products.The physician¿s opinion on the cause of this adverse event is that it was patient condition.The patient regained rhythm, stabilized, and was transferred to icu.The patient did require extended hospitalization as he was admitted to icu instead of having procedure and going home.A generator was not used.

Manufacturer Narrative

The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device number 00001948 and no internal action related to the complaint was found during the review.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: 14599411
• MDR Text Key: 293335001
• Report Number: 2029046-2022-01189
• 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: Other
• Type of Report: Initial
• Report Date: 06/04/2022

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 Expiration Date: 03/22/2023
• Device Model Number: D138501
• Device Catalogue Number: D138501
• Device Lot Number: 00001948
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/10/2022
• Initial Date FDA Received: 06/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2022
• 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: UNKNOWN BRAND ANESTHESIA MONITOR; UNKNOWN BRAND RECORDING SYSTEM
• Patient Outcome(s): Required Intervention; Hospitalization; Life Threatening
• Patient Age: 78 YR
• Patient Sex: Male