MAUDE Adverse Event Report: BIOSENSE WEBSTER INC OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Catalog Number D140901

Device Problems Coagulation in Device or Device Ingredient (1096); Device Contamination with Body Fluid (2317)

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

Event Date 12/12/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a qdot micro¿ catheter and a optrell mapping catheter with trueref technology and both catheters resulted with char.During the procedure, the output power suppression was not applied much.Bull¿s eye worked normally.The procedure was completed as it was.The patient exited the room as usual.After the procedure was completed, the qdot micro catheter and the optrell were pulled out from the patient¿s body.Then, it was found that char was attached on those two catheters.Char was attached near the proximal electrode and was not attached on the tip of the catheter.Ablation could be performed normally, and the irrigation flow were adjusted automatically by the ngen.The patient was anticoagulated.Heparinized normal saline was used.There was no impact onto the patient.During the procedure, the output power suppression was not applied much.Bull¿s eye worked normally.The procedure was completed as it was.The patient exited the room as usual.Additional information was received indicating the physician did not consider the char to be excessive but mentioned that there were some risk to he patient.No intervention was provided.

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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Biosense webster manufacturer's reference number (b)(4) has two reports: (1) mfr # 2029046-2024-00118 for product code d139505 (qdot micro¿ catheter) (2) mfr # for product code d140901 (optrell mapping catheter with trueref technology).

Manufacturer Narrative

On 20-feb-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 a qdot micro¿ catheter and a optrell mapping catheter with trueref technology and both catheters resulted with char.During the procedure, the output power suppression was not applied much.Bull¿s eye worked normally.The procedure was completed as it was.The patient exited the room as usual.After the procedure was completed, the qdot micro catheter and the optrell were pulled out from the patient¿s body.Then, it was found that char was attached on those two catheters.Char was attached near the proximal electrode and was not attached on the tip of the catheter.Ablation could be performed normally, and the irrigation flow were adjusted automatically by the ngen.The patient was anticoagulated.Heparinized normal saline was used.There was no impact onto the patient.During the procedure, the output power suppression was not applied much.Bull¿s eye worked normally.The procedure was completed as it was.The patient exited the room as usual.Device evaluation details: the device was returned to biosense webster inc (bwi) product analysis lab (pal) for evaluation and the evaluation has been completed.Visual inspection and patency test of the returned device were performed following bwi procedures.Visual analysis revealed char residues attached to an electrode.A patency test was performed, and the device was flushing correctly, no obstructed holes were observed.No irrigation issues were observed.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.Since char was observed, the customer complaint was confirmed.It should be noted that product failure is multifactorial.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: OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• 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: 18480639
• MDR Text Key: 333002892
• Report Number: 2029046-2024-00119
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835023015
• UDI-Public: 10846835023015
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K211438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/09/2024

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: D140901
• Device Lot Number: 31161636M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/12/2023
• Initial Date FDA Received: 01/09/2024
• Supplement Dates Manufacturer Received: 02/20/2024; 03/05/2024
• Supplement Dates FDA Received: 02/23/2024; 03/19/2024
• 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; NGEN CONSOLE; QDOT MICRO, BI, TC, D-F; UNK_NGEN PUMP