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

Catalog Number	UNK_OPTRELL MAPPING CATHETER
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	11/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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.Manufacturer's reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent an idiopathic ventricular tachycardia ablation procedure using an optrell mapping catheter with trueref technology.During the mapping phase, the patient experienced a cardiac perforation that required a pericardiocentesis.First, a soundstar catheter sensor error 6150 displayed on the carto 3.The uls cable and catheter connections were reseated without resolution.The catheter was replaced and the issue resolved.After an hour or less then, the 6150 error reappeared but they did not have time to troubleshoot further.In addition, it was reported that the patient experienced a cardiac perforation that resulted in a pericardial effusion.The physician was adjusting the soundstar catheter and discovered the effusion.Confirmed through echo and other specialists.After, the effusion grew and they started monitoring it, they did a ¿tap¿ pericardiocentesis.The smarttouch sf ablation catheter was in use.No ablation was performed and the arrhythmia was never induced.The last known patient status was stable per the initial call.Additional information was received.The patient required prolonged hospitalization because the needle used to do "the tap" (referring to pericardiocentesis) resulted in a gi bleed.Prior to noting the adverse event, ablation was not performed.Event occurred during the mapping phase.The mapping catheter used was the optrell mapping catheter with trueref technology.Transseptal puncture was performed.No error messages regarding irrigated catheter.The outcome of the adverse event is improved.The sensor error 6150 was assessed as non mdr reportable.The incidence of magnetic sensor error was easy detectable by the user.The catheter was inoperable, since it cannot be visualized on the carto system.The user will have to replace the catheter.The most likely consequence was an intraprocedural delay.The potential risk that it could cause or contribute to a serious injury or death was remote.The adverse event was assessed as mdr reportable.
Additional Manufacturer Narrative
Udi related data quality updates only.Correction to the initial mdr, incomplete udi was provided without an explanation.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.No: (b)(4).

• Brand Name: OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY
• 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: 18320272
• Report Number: 2029046-2023-02945
• Device Sequence Number: 15293239
• Product Code: DRF
• UDI-Device Identifier: 10846835023015
• UDI-Public: 10846835023015
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: UNK_OPTRELL MAPPING CATHETER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2023
• Supplement Date Received by Manufacturer: 07/08/2024
• Initial Report FDA Received Date: 12/13/2023
• Supplement Report FDA Received Date: 07/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 KIT-US; SOUNDSTAR ECO SMS 8F CATHETER; SOUNDSTAR ECO SMS 8F CATHETER; THMCL SMTCH SF BID, TC, F-J; UNK ULTRASOUND CABLE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Life Threatening
• Patient Age: 66 YR
• Patient Sex: Male