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

Catalog Number D160903

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 02/28/2024

Event Type  Injury  

Manufacturer Narrative

E1 initial reporter phone: (b)(6).Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.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 Description

It was reported that a patient underwent an atrial fibrillation ablation with a octaray mapping catheter and the patient experienced cardiac tamponade that required pericardiocentesis.Accessed from left femoral vein, and after septal puncture, accessed to left atrium.After making a pre pace map (hra 600ms), pv (pulmonary vein) isolation was performed using a laser balloon.Immediately after the balloon is inflated and fixed for lipv (left-sided pulmonary vein) isolation, blood pressure alarm notified the blood pressure decrease from 92/41 to 78/27.The procedure was stopped, and pericardial fluid was checked with sound star eco catheter.Since pericardial effusion was confirmed, ablation was cancelled, and drainage was performed.This issue was not a defect with the bwi products.After confirmation of pericardial effusion, drainage was performed and the procedure was completed.Ablation was not performed prior to the cardiac tamponade identified.Patient required extended hospitalization.No error messages observed on bwi equipment during the procedure.Pre-pace map was made.Transseptal puncture was performed with rf (radiofrequency) needle.No ablation was performed prior to noting the pericardial effusion.No error messages observed on biosense webster equipment during the procedure.The patient require extended hospitalization.The patient was transferred to another hospital and surgical procedure was performed.

Manufacturer Narrative

On 2-apr-2024, the product investigation was updated with the manufacturing record evaluation.A manufacturing record evaluation was performed for the finished device number lot 31183136l and no internal action related to the complaint was found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• Brand Name: OCTARAY MAPPING 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: 18961661
• MDR Text Key: 338430065
• Report Number: 2029046-2024-00987
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835021127
• UDI-Public: 10846835021127
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K193237
• 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,Followup
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D160903
• Device Lot Number: 31183136L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2023
• 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: SMARTABLATE GENERATOR; SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER; THMCL SMTCH SF BID, TC, D-F; UNSPECIFIED RF NEEDLE
• Patient Outcome(s): Required Intervention; Hospitalization; Life Threatening
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 70 KG