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

Catalog Number D160903

Device Problems Delivered as Unsterile Product (1421); Packaging Problem (3007)

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

Event Date 07/19/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent a paroxysmal atrial fibrillation (afib) ablation procedure with an octaray mapping catheter and the sterility of the device was compromised.It was reported that the octaray mapping catheter outer box/packaging was damaged, and the customer believed the contents sterility was compromised.They opened a new catheter to continue the case.The device was not used on the patient.The pouch seal did not appear to be open.The device was secured in the tray and there was no damage to the device.

Manufacturer Narrative

On (b)(6) 2023, 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

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4) on 15-aug-2023, it was noticed the code of packaging problem (a0205) was inadvertently omitted from field h6.Medical device problem code in the 3500a initial mdr.The code has now been added.

Manufacturer Narrative

It was reported that a patient underwent a paroxysmal atrial fibrillation (afib) ablation procedure with an octaray mapping catheter and the sterility of the device was compromised.It was reported that the octaray mapping catheter outer box/packaging was damaged, and the customer believed the contents sterility was compromised.They opened a new catheter to continue the case.The device was not used on the patient.The pouch seal did not appear to be open.The device was secured in the tray and there was no damage to the device.Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.A visual inspection evaluation of the returned device was performed following bwi procedures.Visual inspection revealed no damage or anomalies on the catheter; however, the packaging of the device was not returned, and for this reason, the product investigation could not be completed.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The event described could not be confirmed as the packaging was not returned.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.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 ref.# (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: 17541652
• MDR Text Key: 321089598
• Report Number: 2029046-2023-01773
• 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,Followup
• Report Date: 09/18/2023

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: 31009376L
• 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: 07/19/2023
• Initial Date FDA Received: 08/14/2023
• Supplement Dates Manufacturer Received: 08/15/2023; 08/28/2023
• Supplement Dates FDA Received: 08/28/2023; 09/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2023
• 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