MAUDE Adverse Event Report: BIOSENSE WEBSTER INC OCTARAY, GALAXY, 48P, 3-3-3-3-3, D-CURVE; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY

Catalog Number D160903

Device Problem Material Deformation (2976)

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

Event Date 07/18/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) cardiac ablation procedure with an octaray, galaxy, 48p, 3-3-3-3-3, d-curve and there was a piece of plastic sticking off one of the electrodes.The plastic piece would not come off when the physician tried removing it.The catheter was replaced, the issue was resolved, and the procedure was continued.No adverse patient consequence was reported.

Manufacturer Narrative

The biosense webster, inc.Product analysis lab received the device for evaluation.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation (afib) cardiac ablation procedure with an octaray, galaxy, 48p, 3-3-3-3-3, d-curve and there was a piece of plastic sticking off one of the electrodes.The plastic piece would not come off when the physician tried removing it.The catheter was replaced, the issue was resolved, and the procedure was continued.No adverse patient consequence was reported.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.A visual inspection evaluation and fourier-transform infrared spectroscopy (ft-ir) analysis of the returned device were performed following bwi procedures.The device evaluation was completed on (b)(6) 2023.Visual analysis revealed that one of the electrodes was lifted, and a foreign material was attached.For this reason, a ft-ir analysis was requested, and it was concluded that the transparent foreign material found on the electrodes is mainly composed of polytetrafluoroethylene (ptfe)-based material.The source of origin cannot be ascertained.A manufacturing record evaluation was performed for the finished device 31009387l number, and no internal actions related to the reported complaint condition were identified.The issue reported by the customer was confirmed.The root cause of the damage observed in the electrode could be related to the excessive force or manipulation of the device during the procedure; however, this cannot be conclusively determined.It should be noted that product failure is multifactorial.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi¿s quality system.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: OCTARAY, GALAXY, 48P, 3-3-3-3-3, 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: 17515931
• MDR Text Key: 321100510
• Report Number: 2029046-2023-01770
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835021127
• UDI-Public: 10846835021127
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193237
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/06/2023

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 Catalogue Number: D160903
• Device Lot Number: 31009387L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/18/2023
• Initial Date FDA Received: 08/11/2023
• Supplement Dates Manufacturer Received: 09/13/2023
• Supplement Dates FDA Received: 10/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2023
• 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; GREEN PATCH SENSOR CABLE KIT; OCTA,LNG,48P,3-3-3-3-3,D-CURVE