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

Catalog Number	UNK_PENTARAY
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	10/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been reported as discarded, 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.Biosense webster manufacturer's reference number (b)(4) has two reports: (1) mfr # 2029046-2023-02701 for product code d134805 (thermocool® smart touch® sf bi-directional navigation catheter).(2) mfr # 2029046-2023-02954 for product code unk_pentaray (pentaray nav high-density mapping catheter) manufacturer's reference number: (b)(4).
Event or Problem Description
Initially this event was reported under the thermocool® smart touch® sf bi-directional navigation catheter (mfr # 2029046-2023-02701).However, additional information was received on 16-nov-2023 stating that the pentaray nav high-density mapping catheter was used for mapping.Therefore, it was assessed to also report this event under the pentaray nav high-density mapping catheter.It was reported that a patient underwent an idiopathic ventricular tachycardia - right (r-idvt) ablation procedure using thermocool® smart touch® sf bi-directional navigation catheter and the pentaray nav high-density mapping catheter and experienced a pericardial effusion which required a pericardiocentesis and surgical repair.While mapping, the patient experienced increased heart rate / decreased blood pressure and pericardial effusion was discovered via the intracardiac ultrasound.A pericardiocentesis was performed and a large amount of blood was removed from the pericardial space.They were not able to control the effusion and the patient was transferred to ct surgery for surgical repair.Additional information received on 16-nov-2023.Pentaray nav high-density mapping catheter was used to map right ventricle outflow tract (rvot).Effusion occurred while attempting to place thermocool® smart touch® sf bi-directional navigation catheter into rvot.No ablation was performed during the procedure.Physician's opinion on the cause of this adverse event was procedure.Patient has improved.Patient required prolonged hospitalization for monitoring post the pericardiocentesis.No transseptal puncture was performed, no evidence of steam pop.It was reported that the event occurred during the mapping phase.

• Brand Name: PENTARAY NAV HIGH-DENSITY MAPPING CATHETER
• Common Device Name: 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: 18326065
• Report Number: 2029046-2023-02954
• Device Sequence Number: 7034710
• Product Code: MTD
• UDI-Device Identifier: 10846835009576
• UDI-Public: 10846835009576
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Date (Section B): 12/14/2023

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_PENTARAY
• 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: 11/16/2023
• Initial Report FDA Received Date: 12/14/2023
• 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: SMARTABLATE GENERATOR KIT-US.; THMCL SMTCH SF BID, TC, D-F.; UNK_CARTO 3.
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 60 KG