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

Model Number	D128201
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Pleural Effusion (2010)
Date of Event	05/04/2023
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 atrial fibrillation (afib) procedure with an unknown pentaray nav high-density mapping catheter.The patient experienced a pleural effusion.During the procedure, the physician noticed that there was low blood pressure with a narrow pulse pressure developing on the patient.The physician was using intracardiac echocardiography (ice) to see if there was a pericardial effusion and they did not observe any significant changes.Upon using fluoroscopy, they observed that the right lung had dropped and there was blood in the lung field.They stated the physician confirmed the injury was a hemopneumothorax injury.The patient had a chest tube inserted and 4 liters of blood was removed from the patient.At this point, the patient had stabilized and was sent to the surgical unit.The physician was unsure of how the injury may have happened.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.

• 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: 17045499
• Report Number: 2029046-2023-01199
• Device Sequence Number: 17425736
• Product Code: MTD
• UDI-Device Identifier: 10846835009576
• UDI-Public: 10846835009576
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 06/01/2023

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 Model Number: D128201
• Device Catalogue Number: UNK_PENTARAY
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2023
• Initial Report FDA Received Date: 06/01/2023
• 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: REPROCESS SDSTR ECO 8F-90 SMS; UNK_C3 CS REFSTAR - DEFLECTABLE; UNK_PENTARAY
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown