MAUDE Adverse Event Report: BIOSENSE WEBSTER INC OCTARAY, PERSEID, 48P, 2-2-2-2-2, D-CURVE; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY

Model Number D160901

Device Problems Entrapment of Device (1212); Patient Device Interaction Problem (4001)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 03/24/2023

Event Type  Injury  

Event Description

It was reported that a patient underwent a cardiac ablation procedure with an octaray, perseid, 48p, 2-2-2-2-2, d-curve catheter and the patient suffered a soft tissue injury requiring hospitalization in the intensive care unit (icu).It was reported that while mapping the right ventricle, the octaray, perseid, 48p, 2-2-2-2-2, d-curve catheter got stuck in/tangled in what appeared to be a chordae tendineae.Although the catheter was able to be removed from the patient¿s body by slow movement, the patient was taken to the icu because the catheter might have caught the chordae tendineae.The movement of the chordae tendineae was subtly suspicious under the echo.The physician's opinions on the relationship between the event and the product is that it was possible that the catheter caught the chordae tendineae.There were no abnormalities observed prior to use or during use of the product.The physician¿s opinion on the cause of this adverse event is that it was procedure related.It is possible that the catheter caught the chordae tendineae.Although rupture/tearing/injury to the chordae tendineae (papillary muscle) is only suspected and not yet confirmed, as the device was caught and required manipulation followed by icu admission, the event is being captured as a soft tissue injury requiring prolonged hospitalization.

Manufacturer Narrative

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.E1.Initial reporter phone: (b)(6).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

On 25-apr-2023, the bwi product analysis lab received the complaint device for evaluation.The product analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.Additionally, the manufactured date and expiration date have been provided.Therefore, fields d4.Expiration date and h4.Device manufacture date have been populated.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

It was reported that a patient underwent a cardiac ablation procedure with an octaray, perseid, 48p, 2-2-2-2-2, d-curve catheter and the patient suffered a soft tissue injury requiring hospitalization in the intensive care unit (icu).It was reported that while mapping the right ventricle, the octaray, perseid, 48p, 2-2-2-2-2, d-curve catheter got stuck in/tangled in what appeared to be a chordae tendineae.Although the catheter was able to be removed from the patient¿s body by slow movement, the patient was taken to the icu because the catheter might have caught the chordae tendineae.The movement of the chordae tendineae was subtly suspicious under the echo.On 17-may-2023, additional information has been received indicating no intervention was conducted.The patient was under observation.The patient¿s outcome from the adverse event was reported as improved.The patient was kept under observation.An ngen generator was used in this case.Device evaluation details: the product was returned to biosense webster inc (bwi) for evaluation and the evaluation was completed on 2-may-2023.A visual inspection and revision of all features were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.A dimensional test was performed, and outer diameters of the device were found within specifications.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.No malfunction was observed during the product analysis.The root cause of the adverse event remains unknown.Physician¿s opinion on the cause of this adverse event was procedure related.The instructions of use contain the following recommendation: the catheter is recommended for use with an 8f guiding sheath because the distal spines may be damaged if used with a sheath that is not compatible.Do not use the catheter in conjunction with transseptal sheaths featuring side holes larger than 1.25mm in diameter.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref#: (b)(4).

• Brand Name: OCTARAY, PERSEID, 48P, 2-2-2-2-2, D-CURVE
• 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: 16771291
• MDR Text Key: 313601866
• Report Number: 2029046-2023-00854
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835021141
• UDI-Public: 10846835021141
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/08/2023
• Device Model Number: D160901
• Device Catalogue Number: D160901
• Device Lot Number: 30955305L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2022
• 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, JAPAN.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 60 YR
• Patient Sex: Male