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 Problems Entrapment of Device (1212); Material Separation (1562); Patient Device Interaction Problem (4001)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/13/2023

Event Type  Injury  

Event Description

It was reported that a patient underwent a cardiac ablation procedure with a pentaray nav high-density mapping eco catheter and a medical device entrapment, spline detachment and foreign body in the patient issues occurred.It was reported the patient was prepped in the centers usual fashion.Prior to the procedure, the physician acknowledged that the instructions for use (ifu) contraindicated the use of the pentaray for patients with mechanical valves.A soundstar catheter was advanced to the right atrium and an image of the mechanical valve was used to contour its position.The pentaray was advanced into the left atrium and used for several hours.Near the end of the procedure, the physician advanced the pentaray towards the mechanical valve and the physician noted that they were unable to move the pentaray and suggested it may be caught in the mechanical valve.The physician advanced the pentaray¿s sheath, which resulted in the pentaray quickly retracting from the mechanical valve.The physician used x-ray imaging and reported that an object appeared to be stuck in one of the leaflets of the mechanical valve.The physician also reported one of the splines of the pentaray was damaged and missing.The packaging of the pentaray was not able to be retrieved.The physician reported that the patient was hemodynamically stable and echocardiography imaging showed that the valve was functioning.The physician ended the case and decided to keep the patient overnight for observation.The damage resulted in wires and/or braid exposure.There was no difficulty in removing the pentaray from the body after it was dislodged from the mechanical valve.Detachment was partial.The physician decided to leave the detached part of the spline in the patient.The physician based this decision on the hemodynamic stability of the patient, and after observing the mechanical valve opening and closing on x-ray.The physician would follow-up the next day with the patient to locate where the detached pentaray spline would embolize and asses the patient further.Ultrasound and x-ray were used to observe mechanical valve movement.

Manufacturer Narrative

The product has not returned for analysis, however, pictures were provided by the customer.Evaluation is still in progress.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.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.The date of event was not provided.As such, field b3.Date of event has been populated with (b)(6) 2023.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 a pentaray nav high-density mapping eco catheter and a medical device entrapment, spline detachment and foreign body in the patient issues occurred.It was reported the patient was prepped in the centers usual fashion.Prior to the procedure, the physician acknowledged that the instructions for use (ifu) contraindicated the use of the pentaray for patients with mechanical valves.A soundstar catheter was advanced to the right atrium and an image of the mechanical valve was used to contour its position.The pentaray was advanced into the left atrium and used for several hours.Near the end of the procedure, the physician advanced the pentaray towards the mechanical valve and the physician noted that they were unable to move the pentaray and suggested it may be caught in the mechanical valve.The physician advanced the pentaray¿s sheath, which resulted in the pentaray quickly retracting from the mechanical valve.The physician used x-ray imaging and reported that an object appeared to be stuck in one of the leaflets of the mechanical valve.The physician also reported one of the splines of the pentaray was damaged and missing.The physician reported that the patient was hemodynamically stable and echocardiography imaging showed that the valve was functioning.The physician ended the case and decided to keep the patient overnight for observation.Device investigation details: a picture was received for evaluation.The picture was analyzed following biosense webster's procedures.According to pictures provided by the customer, one spline was observed detached from the tip leaving internal components exposed.No conditions that might contributed to the reported event were found.The root cause of the adverse event could be related to the usage of the device with a patient with mechanical mitral valve.The instructions for use (ifu) contain the following contraindications: do not use the pentaray® catheters in patients with prosthetic valves.The manufacturing record evaluation (mre) could not be performed since the lot # was not provided.The customer complaint was confirmed based on the picture received.The device has not been returned for analysis and a root cause is unable to be assigned based on the current evidence.If the device is received in the future, the product investigation will be performed and updated accordingly, and any action will be taken if necessary.Note: field b3.Date of event has been updated from jan/1/2023 to apr/13/2023.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: 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: 16916993
• MDR Text Key: 315066530
• Report Number: 2029046-2023-01010
• Device Sequence Number: 1
• Product Code: MTD
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 04/13/2023
• Initial Date FDA Received: 05/11/2023
• Supplement Dates Manufacturer Received: 05/24/2023
• Supplement Dates FDA Received: 06/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNK_PENTARAY; UNK_SOUNDSTAR
• Patient Outcome(s): Required Intervention