MAUDE Adverse Event Report: BIOSENSE WEBSTER INC OPTRELL, 48 ELECTRODES, F-J; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	D140902
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Device Contamination with Body Fluid (2317)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an idvt ablation procedure with an optrell catheter and the carto 3 system was unable to visualize the splines of the optrell catheter.The medical team could only see the shaft of the catheter after mapping the right ventricle.They tried reseating the catheter with no resolution.They switched to the ablation catheter to continue mapping and continued the procedure.No patient consequences were reported.After the procedure, it was noticed that the electrodes on the optrell catheter were black on the carto 3 system.They had heparinized the patient right before they went to the left side of the heart when they noticed the black electrodes.The optrell catheter remained in the right atrium after the black electrodes were noticed and was not used again for the rest of the procedure.After the procedure, upon inspection of the optrell catheter after being taken out of the body, they noticed coagulation on the same electrodes that were showing up black on the carto 3 system.Visualization issue is not mdr-reportable.Thrombus/clot is mdr-reportable.
Additional Manufacturer Narrative
Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.However, a picture was received for evaluation following biosense webster's procedures.According to pictures provided by the customer, black rings were observed on the carto 3 screen, also, a thrombus/clot was observed on some electrodes of the optrell catheter.A manufacturing record evaluation was performed for finished device number 30835542, and no internal actions related to the reported complaint condition were identified.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
On 12-jul-2023, the bwi product analysis lab received the device for evaluation.Device evaluation details: the device was returned to biosense webster for evaluation.A visual inspection, magnetic sensor functionality, and patency test of the returned device were performed in accordance with bwi procedures.The device was visually inspected, and thombus/clot attached on one on electrode of the device's tip was observed.A magnetic sensor functionality test was performed and some black rings were observed on the carto 3 screen.The black rings were displayed on the same electrodes that the thombus/clot was observed.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 number lot 30835542m and no internal actions related to the complaint were found during the review.The issues reported by the customer were confirmed.The visualization issue reported by the customer could be related with the thombus/clot observed during the analysis.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 reference number: (b)(4).

• Brand Name: OPTRELL, 48 ELECTRODES, F-J
• Common Device Name: 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: 17192843
• Report Number: 2029046-2023-01374
• Device Sequence Number: 15278768
• Product Code: DRF
• UDI-Device Identifier: 10846835023022
• UDI-Public: 10846835023022
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K211438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/21/2023
• Device Model Number: D140902
• Device Catalogue Number: D140902
• Device Lot Number: 30835542M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2023
• Supplement Date Received by Manufacturer: 07/12/2023
• Initial Report FDA Received Date: 06/23/2023
• Supplement Report FDA Received Date: 08/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2022
• 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: CARTO 3 SYSTEM; SMARTABLATE GENERATOR; SMARTABLATE PUMP
• Patient Sex: Unknown