MAUDE Adverse Event Report: BIOSENSE WEBSTER INC OCTARAY, PERSEID, 48P, 2-2-2-2-2, D-CURVE; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY

Catalog Number D160901

Device Problems Signal Artifact/Noise (1036); Break (1069)

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

Event Date 09/15/2023

Event Type  malfunction  

Manufacturer Narrative

E1 initial reporter phone: (b)(6).The product investigation was completed.Device evaluation details: the product was returned to biosense webster (bwi) for evaluation.A visual inspection and electrical evaluation of the returned device were performed following bwi procedures.Visual analysis revealed two electrodes lifted with sharp edges.The root cause of the damage could be related to the shipping/ handling process, however, this cannot be conclusively determined there are control inspection points to avoid these issues.This issue could be attributed to the reported event.An electrical test was performed, however, this failed due to an open circuit found in the tip area and the lifted electrode.The issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.A manufacturing record evaluation was performed for the finished device number 31090711l, and no internal action was found during the review.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 reference number: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a octaray, perseid, 48p, 2-2-2-2-2, d-curve and post procedure the bwi product analysis lab received the device for evaluation and identified that two electrodes were lifted with sharpened edges.There was also an opened circuit at the tip area near a lifted electrode.During the procedure, noise occurred in both labo and carto 3 at the g spine when connecting the catheter.The ablation was able to be stopped manually (with either the stop button or foot pedal release).The noise was not resolved by replacing the cable, but was resolved by replacing the octaray to another new one.The procedure was then completed without any problems.No patient consequences were reported.

• Brand Name: OCTARAY, PERSEID, 48P, 2-2-2-2-2, D-CURVE
• 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: 18432639
• MDR Text Key: 332503098
• Report Number: 2029046-2024-00028
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835021141
• UDI-Public: 10846835021141
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K193237
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D160901
• Device Lot Number: 31090711L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2023
• Date Manufacturer Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2023
• 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: CARTO 3 SYSTEM.