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

Model Number D128211

Device Problems Break (1069); Display or Visual Feedback Problem (1184); Detachment of Device or Device Component (2907); Material Protrusion/Extrusion (2979)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/11/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial tachycardia (at) ablation procedure with a pentaray nav high-density mapping eco catheter wherein a broken tip issue occurred exposing internal components.It was reported there was a visualization issue during the operation, device was recognized by the carto but the "17 "electrode was not visualized on the carto 3 system while other electrodes were visualized normally.A second device was used to complete the operation.There was no adverse event reported on patient.Additional information received indicated there was noise on all ecg (bs + ic) channels of the carto 3 system.The physician did have other intact ecg signal available to monitor patient heart rhythm while the catheter was in the patient.There was damage to the catheter that resulted in wire exposure.There was no sharp or lifted rings.There was no resistance during insertion or removal of the catheter.The catheter was not pre-shaped.A synaptic transseptal sheath, model is l1/l catheter sheath was used in this case.

Manufacturer Narrative

The product has not returned for analysis, however, pictures were provided by the customer.Evaluation is still in progress.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.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 ref.# (b)(4).

Manufacturer Narrative

It was reported that a patient underwent an atrial tachycardia (at) ablation procedure with a pentaray nav high-density mapping eco catheter wherein a broken tip issue occurred exposing internal components.It was reported there was a visualization issue during the operation, device was recognized by the carto but the "17 "electrode was not visualized on the carto 3 system while other electrodes were visualized normally.A second device was used to complete the operation.There was no adverse event reported on patient.Device evaluation details: on 15-jun-2023, the device was returned to biosense webster inc (bwi) for evaluation.A visual inspection, magnetic sensor functionality, and electrical test of the returned device were performed following bwi procedures and the evaluation has been completed.Visual analysis revealed that the tip of one of the splines was detached.A magnetic sensor functionality and electrical test was performed and the device failed both tests due to the condition observed with the spline.The damage observed in the spline could be related to the excessive force on the handling of the device during the procedure; however, this cannot be conclusively determined.Additionally, a picture was received from the customer.According to pictures provided by the customer, the electrode 17 was observed black on the carto 3 screen.Also, the pictures shown that one of the splines of the pentaray catheter was broken with exposed wires.Also, a signal noise was observed on the carto 3 screen.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.The instructions for use contain the following recommendations: the catheter is recommended for use with an 8.5 f guiding sheath because the distal spines may be damaged if used with a sheath that is not compatible.Do not use the catheter in conjunction with a transseptal sheath featuring side holes larger than 1.25 mm in diameter.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

• Brand Name: PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER
• 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: 17070672
• MDR Text Key: 317219687
• Report Number: 2029046-2023-01233
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835012255
• UDI-Public: 10846835012255
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K123837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D128211
• Device Catalogue Number: D128211
• Device Lot Number: 30771005L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/11/2023
• Initial Date FDA Received: 06/06/2023
• Supplement Dates Manufacturer Received: 06/15/2023
• Supplement Dates FDA Received: 06/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2022
• 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: PENTARAY NAV ECO 7FR, D, 2-6-2; SYNAPTIC TRANSSEPTAL SHEATH, MODEL IS L1/L