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

Catalog Number UNK_OCTARAY NAV

Device Problems Device Contamination with Body Fluid (2317); Material Deformation (2976); Patient Device Interaction Problem (4001)

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

Event Date 09/22/2022

Event Type  malfunction  

Manufacturer Narrative

The bwi product analysis lab received photos of the complaint device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturer record evaluation cannot be conducted because the no lot number was provided by the customer.This report is being submitted pursuant to the provisions of 21 cfr, part 4.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 reference number: (b)(4).

Event Description

It was reported that an unknown patient underwent a redo pulmonary vein isolation (redo pvi) with an unknown octaray nav catheter.There was charring and burn marks on the octaray catheter they had some charring and burning marks on the octaray catheter.They had no problem during the case, they had very good signal, good ablation vision and they also used qdot and cs catheters and everything was ok.The procedure was completed with no patient consequences or delay.No errors reported with carto and ngen generator.The carto/ ngen did not display any error related to temperature or any other issue.The char was detected after use.There was no patient consequence.The ablation catheter and the octaray catheter were used at the same time.The ablation catheter and the octaray catheter were near each other.Picture of the burning marks on octaray catheter were received.The char /coagulum/thrombus/clot was located on different splines of the octaray catheter.Burn marks on the catheter is mdr-reportable.

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).It was reported, ¿there was charring and burn marks on the octaray catheter.The char / coagulum/thrombus/clot was located on different splines of the octaray catheter.¿ initially the event was coded under the h6.Medical device problem code of ¿material deformation (a0406)¿.During an internal review on 14-nov-2022, it was determined that the code of thrombus/ clot ¿patient device interaction problem (a01)¿ should have also been reported under the 3500a initial to capture event with unknown octaray nav catheter in this complaint.Therefore, updated the h6.Medical device problem code field to include ¿patient device interaction problem (a01)¿.

Manufacturer Narrative

On 1-mar-2023, the bwi product analysis lab received the device for evaluation.The 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 reference number: (b)(4).

Manufacturer Narrative

On 18-jan-2023, the product investigation was completed based on received photos of the device.Device investigation details: according to pictures provided by the customer, char was observed on the splines of the octaray catheter, no other damages or anomalies were observed on the electrodes of the catheter.The manufacturing record evaluation (mre) cannot be performed due to the lot number was not being provided.The customer complaint was confirmed based on the picture received.The device has not been returned for analysis and a root cause is unable to be assigned based on the current evidence.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

On 5-apr-2023, the product investigation was completed.It was reported that an unknown patient underwent a redo pulmonary vein isolation (redo pvi) with an unknown octaray nav catheter.There was charring and burn marks on the octaray catheter.They had some charring and burning marks on the octaray catheter.They had no problem during the case, they had very good signal, good ablation vision and they also used qdot and cs catheters and everything was ok.The procedure was completed with no patient consequences or delay.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.A visual inspection of the returned device was performed following bwi procedures.Visual analysis was performed, and only the tip of the catheter was returned for investigation.The catheter piece was inspected from the top and bottom and residues of reddish material were observed, this could be related to the char/thrombus/clot reported by the customer.The issue reported by the customer was confirmed.Char is a physical phenomenon of rf, it can be the normal result of the ablation process.Monitoring the temperature from the electrode during the application of rf current ensures that the irrigation flow rate is being maintained.Using tip temperature to guide ablation could result in deeper lesions and an increased risk for collateral damage.Manufacturer record evaluation cannot be conducted because the no lot number was provided by the customer.(the mre was not identifiable on the returned device).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: UNKNOWN OCTARAY NAV 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15613118
• MDR Text Key: 307198674
• Report Number: 2029046-2022-02541
• Device Sequence Number: 1
• Product Code: MTD
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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,Followup,Followup,Followup
• Report Date: 05/03/2023

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: UNK_OCTARAY NAV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/22/2022
• Initial Date FDA Received: 10/16/2022
• Supplement Dates Manufacturer Received: 11/14/2022; 01/18/2023; 02/16/2023; 04/05/2023
• Supplement Dates FDA Received: 12/09/2022; 01/20/2023; 03/10/2023; 05/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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: CARTO 3 SYSTEM; CARTO VISITAG MODULE; NGEN RF GENERATOR; QDOT MICRO; UNSPECIFIED PUMP