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

Model Number D160906

Device Problems Delivered as Unsterile Product (1421); Component Missing (2306)

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

Event Date 08/17/2022

Event Type  malfunction  

Event Description

It was reported that a patient underwent a atrial fibrillation ablation procedure with a octaray, galaxy, 48p, 3-3-3-3-3, f-curve catheter and a missing pouch and sterilization issue occurred.It was reported by the bwi representative, that the packaging of the octaray, galaxy, 48p, 3-3-3-3-3, f-curve catheter looked like the thin plastic that surrounds the catheter was omitted, and the inside of the catheter was split apart.By thin plastic cover they meant the pouch; the pouch was missing.The catheter was replaced, and the issue was resolved.The case continued.There was no patient consequence.There was slight damage to the outer box.The device was not secured properly in the tray, hard plastic tray was apart, and the catheter was coming out.There was no damage to the device due to any part of the packaging being damaged.

Manufacturer Narrative

The bwi product analysis lab received the complaint device for evaluation.The product 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 a atrial fibrillation ablation procedure with a octaray, galaxy, 48p, 3-3-3-3-3, f-curve catheter and a missing pouch and sterilization issue occurred.It was reported by the bwi representative, that the packaging of the octaray, galaxy, 48p, 3-3-3-3-3, f-curve catheter looked like the thin plastic that surrounds the catheter was omitted, and the inside of the catheter was split apart.By thin plastic cover they meant the pouch; the pouch was missing.The catheter was replaced, and the issue was resolved.The case continued.There was no patient consequence.Device evaluation details the product was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.Bwi conducted a general inspection through a visual inspection.Visual analysis revealed no damages or anomalies on the catheter.Further analysis could not be performed as the packaging was not returned to the lab.According to the photo investigation, no pouch was observed the corresponding investigation was performed, and it was possible to determine that the customer complaint is not related to the manufacturing process.A manufacturing record evaluation was performed and no internal actions related to the reported complaint condition were identified.The customer complaint was not confirmed.As part of bwi¿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: OCTARAY, GALAXY, 48P, 3-3-3-3-3, F-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: 15993414
• MDR Text Key: 308108704
• Report Number: 2029046-2022-03144
• Device Sequence Number: 1
• Product Code: MTD
• 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: 01/27/2023

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 Expiration Date: 05/05/2023
• Device Model Number: D160906
• Device Catalogue Number: D160906
• Device Lot Number: 30804749L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/07/2022
• Initial Date FDA Received: 12/16/2022
• Supplement Dates Manufacturer Received: 01/11/2023
• Supplement Dates FDA Received: 01/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2022
• 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: OCTA,LNG,48P,3-3-3-3-3,F-CURVE