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

Catalog Number D160901

Device Problems Display or Visual Feedback Problem (1184); Contamination /Decontamination Problem (2895)

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

Event Date 01/17/2024

Event Type  malfunction  

Manufacturer Narrative

Device investigation details: additional information received indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device number lot 31205943l and no internal action related to the complaint was found during the review.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.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).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with an octaray mapping catheter and a piece of plastic string that was coming off the octaray mapping catheter.It was reported that the octaray catheter was not visualized on the carto 3 system.The caller noted that there were no errors displayed on the carto 3 system.The octaray catheter connections were re-seated without resolution.The physician then noticed on intracardiac echocardiography (ice) that there was foreign material coming off the octaray catheter.The octaray catheter was removed from the body, and it was confirmed that there was a piece of plastic string that was coming off the octaray catheter.The caller noted that the plastic string "peeled off easily." the octaray catheter was replaced and the issue was resolved.The procedure continued.There was no patient consequence.The customer¿s reported visualization issue on the carto 3 system is not considered to be mdr reportable since the potential risk that it could cause or contribute to a serious injury or death is remote.

Manufacturer Narrative

On 6-mar-2024, 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.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 an atrial fibrillation (afib) ablation procedure with an octaray mapping catheter and a piece of plastic string that was coming off the octaray mapping catheter.It was reported that the octaray catheter was not visualized on the carto 3 system.The caller noted that there were no errors displayed on the carto 3 system.The octaray catheter connections were re-seated without resolution.The physician then noticed on intracardiac echocardiography (ice) that there was foreign material coming off the octaray catheter.The octaray catheter was removed from the body, and it was confirmed that there was a piece of plastic string that was coming off the octaray catheter.The caller noted that the plastic string "peeled off easily." the octaray catheter was replaced and the issue was resolved.The procedure continued.There was no patient consequence.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.A visual inspection and magnetic sensor functionality test of the returned device were performed following bwi procedures.Visual analysis revealed that no damage or anomalies on the device.No foreign material was observed during the inspection.A magnetic sensor functionality test was performed, and the device was visualized and recognized correctly; no magnetic visualization were observed.A manufacturing record evaluation was performed, and no internal action related to the reported complaint were identified.The issues reported by the customer could not be replicated 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 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: 18660366
• MDR Text Key: 334798183
• Report Number: 2029046-2024-00411
• 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,Followup
• Report Date: 02/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D160901
• Device Lot Number: 31205943L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/23/2023
• 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: UNK_CARTO 3.