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

Catalog Number	D160906
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with an octaray mapping catheter and while setting up for the procedure, it was noticed that the octaray¿ catheter packaging was missing the hard plastic sterile packaging (the hard blue plastic sterile package that the octaray catheter itself is taken out of in the sterile field).The sterility of the octaray¿ catheter was compromised.There was no pouch seal present at all.The octaray¿ catheter was replaced and the procedure continued.No adverse patient consequence was reported.
Additional Manufacturer Narrative
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with an octaray mapping catheter and while setting up for the procedure, it was noticed that the octaray¿ catheter packaging was missing the hard plastic sterile packaging (the hard blue plastic sterile package that the octaray catheter itself is taken out of in the sterile field).The sterility of the octaray¿ catheter was compromised.There was no pouch seal present at all.The octaray¿ catheter was replaced and the procedure continued.No adverse patient consequence was reported.Device investigation details: the device was returned to johnson & johnson medtech (j&j medtech) for evaluation.Following j&j medtech procedures, a visual inspection was performed.Visual inspection revealed no damage or anomalies on the device.No further analysis could be performed, as the original packaging (including pouch and tray) were returned.A manufacturing record evaluation was performed for the finished device number, and no internal actions related to the reported complaint were identified.The sterilization issue reported by the customer cannot be evaluated with the information available.The potential cause may be attributed to improper shipping/storage of the device.However, it cannot be established.The instructions for use states: ¿inspect the sterile packaging and catheter prior to use.¿store the catheter per the recommended storage conditions on the product label.As part of johnson and johnson medtech¿s quality process, all devices are manufactured, inspected, and released to approved specifications.This product complaint will be addressed through the quality system.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: pc-(b)(4).

• Brand Name: OCTARAY MAPPING CATHETER
• Common Device Name: 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: 21088156
• Report Number: 2029046-2025-00059
• Device Sequence Number: 17871709
• Product Code: MTD
• UDI-Device Identifier: 10846835021134
• UDI-Public: (01)10846835021134(11)240715(17)270714(10)31388053L
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K193237
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: D160906
• Device Lot Number: 31388053L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2024
• Supplement Date Received by Manufacturer: 01/22/2025
• Initial Report FDA Received Date: 01/06/2025
• Supplement Report FDA Received Date: 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FARAPULSE¿ GENERATOR.
• Patient Sex: Unknown