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

Catalog Number D160903

Device Problems Break (1069); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 11/28/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with an octaray mapping catheter and a spine defect was confirmed before opening the catheter.The agency, physician, and reporter checked and determined a defective spine before opening the octaray catheter.¿the root of the entire spine was broken and not opened¿.The procedure was completed without patient consequence.

Manufacturer Narrative

The biosense webster inc.(bwi) product analysis lab received the device for evaluation on 11-jan-2024.The device evaluation was completed on 18-jan-2024.It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with an octaray mapping catheter and a spine defect was confirmed before opening the catheter.The agency, physician, and reporter checked and determined a defective spine before opening the octaray catheter.¿the root of the entire spine was broken and not opened¿.The procedure was completed without patient consequence.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.A visual inspection evaluation of the returned device was performed following bwi procedures.Visual analysis of the returned sample revealed no damage or anomalies on the device.The tip-shaft transition and spines were found in good condition.The picture provided by the customer does not show any damage with the catheter.A manufacturing record evaluation was performed for the finished device 31121739l number, and no internal action related to the complaint condition was identified.Additionally, the manufactured and expiration dates have been provided.Therefore, fields d4.Expiration date and h4.Device manufacture date have been populated.All units are inspected prior to leaving the facility as there are functional tests and inspections at control points based on the process flow diagram (pfd), per its part number, to avoid this type of damage from leaving the facility.The issue reported by the customer could not be confirmed during the product investigation.Other issues or circumstances may have occurred during the usage of the device that compromised its performance.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).

• Brand Name: OCTARAY MAPPING 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: 18400789
• MDR Text Key: 331506030
• Report Number: 2029046-2023-03082
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835021127
• UDI-Public: 10846835021127
• 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,Followup
• Report Date: 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2023
• 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: 31121739L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2023
• 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: OCTA,LNG,48P,3-3-3-3-3,D-CURVE; OCTA,LNG,48P,3-3-3-3-3,D-CURVE