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

Catalog Number UNK_PENTARAY

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Arrest (1762)

Event Date 01/31/2024

Event Type  Injury  

Manufacturer Narrative

Since no device has been received for analysis, 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 # 2029046-2024-00640 for product code d139401 (qdot micro¿ catheter) (2) mfr # 2029046-2024-00641 for product code unk_pentaray (pentaray nav high-density mapping eco catheter).

Event Description

It was reported a patient underwent an atrial fibrillation (afib) cardiac ablation procedure which included a pentaray nav high-density mapping eco catheter and a qdot micro¿ catheter and the patient experienced cardiac arrest which required prolonged hospitalization.It was reported that the patient has a sick heart due to heart failure and previous myocardial infarction.They mapped the left atrium during afib using a pentaray and mapped a bit from the qdot catheter as well.The patient¿s blood pressure went down after finishing almost the whole map and they cardioverted the patient.There was low blood pressure still and kept decreasing.The patient went into cardiac arrest and cardiopulmonary resuscitation (cpr) was performed.The patient ¿got fast sr¿ and was stable.The patient had a stable rhythm but was kept sedated after.The procedure was canceled, and no ablation was performed.The physician¿s opinion on the cause of the adverse event was that it was patient condition related.The patient required prolonged hospitalization as the patient was still sedated and was waiting for magnetic resonance imaging (mri) to check brain injuries.The most suspected device is the pentaray mapping catheter as the event occurred during mapping.However, as a conservative measure, the qdot is being captured as the reported event indicated that the mapping was done from the qdot catheter as well.

• 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: 18784528
• MDR Text Key: 336294253
• Report Number: 2029046-2024-00641
• Device Sequence Number: 1
• Product Code: MTD
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_PENTARAY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: No
• 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
• Treatment: NGEN RF GENERATOR.; QDOT MICRO, UNI, TC , D.
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male