MAUDE Adverse Event Report: BIOSENSE WEBSTER INC PENTARAY NAV ECO; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY

Model Number D128211

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Transient Ischemic Attack (2109); Thrombosis/Thrombus (4440)

Event Date 11/22/2022

Event Type  Injury  

Event Description

It was reported that an 62-year-old male patient weighing 66.0 kg underwent an atrial fibrillation (afib) ablation procedure with a 28 mm balloon ablation catheter and a pentaray.The patient suffered a transient ischemic attack due to emboli requiring prolonged hospitalization.The physician states that today they tried to make a heliostar patient, but after a transseptal procedure was performed, heparin was given, and they changed to a 14f sheath (guidestar), a pentaray map of the la was made, and heliostar was placed in the sheath but not advanced, as patient fell ill with flickering before the eyes and paralysis on the right arm and signs of apoplexy, act was over 350.Procedure stopped; sheath removed.The patient's symptoms disappeared within 30 minutes, and he is now being taken to the ct scanner - thus expected tci (transitory cerebral ischemia).Procedure was stopped and catheters were removed when the event occurred.The procedure was not successfully completed.No fragments were generated.There were patient consequences of transitory cerebral ischemia.Other medical intervention of ct scan was required.The patient is part of a clinical study.The physician¿s opinion on the cause of this adverse event was cerebral ischemia due to emboli.Intervention being provided was heliostar afib ablation.The patient outcome of the adverse event is fully recovered.The patient require extended hospitalization because of the adverse event, they stayed for 2 extra days to start up medicine for afib instead of ablation.Other relevant history includes apoplexia that occurred 4 mths ago.An ngen fg20330040 generator was used.No ablation was delivered.There was no evidence of blood thrombus / clot during the procedure.Correct catheter settings were selected on the generator.It is an investigator-initiated study supported by bw.This complaint will be reported under the pentaray as it was reported that the event occurred after the use of the pentaray and that the heliostar was placed in the sheath but not advanced, as patient fell ill with flickering before the eyes and paralysis on the right arm and signs of apoplexy.Since the event is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or surgical 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.

Manufacturer Narrative

Initial reporter phone: (b)(6).Since no device has been received for analysis, 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.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc.Or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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: PENTARAY NAV ECO
• Type of Device: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• 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 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16012086
• MDR Text Key: 305785921
• Report Number: 2029046-2022-03186
• Device Sequence Number: 1
• Product Code: MTD
• Combination Product (y/n): N
• PMA/PMN Number: K123837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D128211
• Device Catalogue Number: D128211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2022
• Was Device Evaluated by Manufacturer?: No
• 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: BALLOON ABLATION CATHETER.; GUIDESTAR SHEATH.; NGEN GENERATOR.
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 66 KG