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

Model Number D128211

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 01/03/2023

Event Type  Injury  

Event Description

It was reported that a male patient underwent an isvt ¿ left ablation procedure with a pentaray nav high-density mapping eco catheter and the patient experienced hypotension requiring surgical intervention and prolonged hospitalization.It was reported that after 1 hour of mapping in sinus rhythm, the physician decided to stimulate to induce tachycardia and map it.After two minutes, the patient's blood pressure and capnia began to drop.The nurse shocked him several times to restore sinus rhythm.Blood pressure was still poor.Ultrasound showed dissociation, the patient was massaged, and a surgical team intervened to stabilize the patient (intra-aortic balloon counterpulsation).Surgery was delayed due to the reported event.Procedure was not successfully completed.No fragments generated.Patient was hospitalized in intensive care unit.Additional event information received indicated that during use of pentaray nav high-density mapping eco catheter.The physician¿s opinion on the cause of this adverse event is that it was patient condition.Patient has fully recovered.Patient did require extended hospitalization as his heart needed surgical assistance to pump blood and not because of the cancellation but because of the patient¿s health condition, not the other way around.Patient was under general anesthesia and the reporter is unable to provide timeline of duration of the anesthesia.Transseptal puncture was performed prior to the case cancellation.

Manufacturer Narrative

Device investigation details: the device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.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.Manufacturer's ref.# (b)(4).

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4) on 24-mar-2023, it was noticed the incorrect health impact code of "recognised device or procedural complication (f15)" was reported in the 3500a initial medwatch report.The correct code is "surgical intervention (f19)".This code has now been added in field h6.Health effect - impact code.

• Brand Name: PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER
• Type of Device: 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: 16275117
• MDR Text Key: 308523857
• Report Number: 2029046-2023-00189
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835012255
• UDI-Public: 10846835012255
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K123837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D128211
• Device Catalogue Number: D128211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Sex: Male