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

Catalog Number UNK_OCTARAY NAV

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 01/12/2024

Event Type  Injury  

Event Description

It was reported a patient underwent a paroxysmal atrial fibrillation (afib) ablation procedure with a preface® guiding sheath with multipurpose curve and a octaray mapping catheter and patient experienced cardiac tamponade treated with a pericardiocentesis, surgical intervention for a drain extended hospitalization.After a cartosound map was created, the transspetal procedure was performed.While mapping in the left atrium with the octaray mapping catheter, it was noticed that the patient's blood pressure dropped.A quick survey with intracardiac echo (ice) catheter revealed a large effusion.The afib procedure was aborted and a pericardiocentesis was performed and a drain was secured in place.The patient was stable and transferred to the intensive care unit (icu) for continued observation.Patient¿s outcome was reported to be improved.It is believed that possibly the bwi product in use at the time of effusion onset.Physician¿s opinion on the cause of this adverse event is possibly when going transseptal or initial mapping with octaray.

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.Biosense webster manufacturer's reference number: (b)(4) has two reports: (1) mfr#: 2029046-2024-00373 for product (preface® guiding sheath with multipurpose curve).(2) mfr#: for product (octaray mapping catheter).

• 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: 18628026
• MDR Text Key: 334369515
• Report Number: 2029046-2024-00374
• Device Sequence Number: 1
• Product Code: MTD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193237
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_OCTARAY NAV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2024
• 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
• Treatment: UNKNOWN ICE CATHETER.; UNK_PREFACE SHEATH.
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 81 KG