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

Model Number D128211

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Low Blood Pressure/ Hypotension (1914); Ventricular Tachycardia (2132)

Event Date 05/04/2020

Event Type  Death  

Manufacturer Narrative

The biosense webster inc.(bwi) product analysis lab (pal) received the deice for evaluation.Upon initial inspection, no visual damage or anomalies observed.The investigational analysis completed 5/26/2020.The device was visually inspected and it was found in good conditions.Then, deflection test was performed and it was found within specifications.The catheter was deflecting correctly.An electrical test was performed on the catheter and it was found within specifications.No electrical malfunction was observed.Then, magnetic sensor functionality was tested on carto and the catheter was properly visualized and no errors were observed.Then, irrigation test was performed and it was found within specifications.The catheter was irrigating correctly.No irrigation issues were observed.No malfunctions were observed during the product analysis.A manufacturing record evaluation was performed and no internal actions were identified.The customer complaint cannot be confirmed.The catheter passed all specifications.The root cause of the adverse event remains unknown.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(4).

Event Description

It was reported that a patient underwent an ischemic ventricular tachycardia (isvt) ablation procedure with a pentaray nav high-density mapping eco catheter and suffered ventricular tachycardia, cardiac arrest and death.During the procedure the patient went into ventricular tachycardia (vt) while mapping with the pentaray catheter.The patient¿s blood pressure decreased, and pace termination was not successful.Defibrillation was performed, but the patient¿s heart rhythm degenerated into a pulseless electrical activity (pea).A code was called but the patient expired.No radio frequency energy delivery was performed.No biosense webster inc.(bwi) product malfunctions were reported.Physician¿s causality opinion was not provided.The medical safety officer (mso) reviewed this event and recommended to conservatively report it under the pentaray catheter as the relationship between the catheter and the event is unclear.Should more information become available, it will be reviewed and processed accordingly.

• Brand Name: PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER
• Type of Device: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• 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 drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 10107632
• MDR Text Key: 193262661
• Report Number: 2029046-2020-00643
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835012255
• UDI-Public: 10846835012255
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123837
• 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: 05/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/30/2023
• Device Model Number: D128211
• Device Catalogue Number: D128211
• Device Lot Number: 30351878L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2020
• Date Manufacturer Received: 05/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2020
• 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
• Patient Outcome(s): Death; Required Intervention