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

Catalog Number D128211

Device Problems Break (1069); Entrapment of Device (1212); Off-Label Use (1494); Patient Device Interaction Problem (4001)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

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.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation ablation procedure with a pentaray nav high-density mapping eco catheter and the patient experienced foreign body from medical device entrapment in the patient's prosthetic mitral valve.The patient presented with atrial fibrillation and a prosthetic mitral valve as well as a prosthetic aortic valve.When cautiously mapping the left atrium in sinus rhythm, one pentaray nav high-density mapping eco catheter spline got caught in the mechanical mitral valve.The physician was not able to move the catheter anymore and the pentaray nav high-density mapping eco catheter icg shows massive noise on the pentaray nav high-density mapping eco catheter 13-14 and 15-16.On fluoroscopy as well as on carto it could be seen that the spline was stuck into the mitral valve.Due to the continuous opening and closing of the valve resulting in mechanical stress for the spline and due to the physician trying to free the catheter, the spline ripped of the catheter.The catheter could then be removed from the heart but the spline was still stuck in the mechanical mitral valve.After some minutes, the spline released from the valve on its own and passed into the left ventricle.Moreover, one electrode solved from the spline and separately positioned in the left ventricle, which could be seen on fluoroscopy.The fragments seemed to be stuck into the trabeculae and did not move anymore.Nevertheless, the physician decided to continue and successfully finished the procedure.After the procedure, the patient was awake and responsive, but the fragments of the pentaray nav high-density mapping eco catheter spline still remained in the left ventricle.Additional information was provided which indicated that the patient¿s outcome was unchanged.However, as reported "already mentioned in the event description the fragments still remained in the patient¿s body but the patient had no severe consequences as the fragments grew in the endothelium".One arm of the pentaray nav high-density mapping eco catheter was stuck in the mechanical mitral valve and ripped off.It was four-armed (splines) after removing the catheter from the patient¿s body.

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation ablation procedure with a pentaray nav high-density mapping eco catheter.The patient presented with atrial fibrillation and a prosthetic mitral valve as well as a prosthetic aortic valve.When cautiously mapping the left atrium in sinus rhythm, one pentaray nav high-density mapping eco catheter spline got caught in the mechanical mitral valve.The physician was not able to move the catheter anymore and the pentaray nav high-density mapping eco catheter icg shows massive noise on the pentaray nav high-density mapping eco catheter 13-14 and 15-16.On fluoroscopy as well as on carto it could be seen that the spline was stuck into the mitral valve.Due to the continuous opening and closing of the valve resulting in mechanical stress for the spline and due to the physician trying to free the catheter, the spline ripped of the catheter.The catheter could then be removed from the heart but the spline was still stuck in the mechanical mitral valve.After some minutes, the spline released from the valve on its own and passed into the left ventricle.Moreover, one electrode solved from the spline and separately positioned in the left ventricle, which could be seen on fluoroscopy.The fragments seemed to be stuck into the trabeculae and did not move anymore.Nevertheless, the physician decided to continue and successfully finished the procedure.After the procedure, the patient was awake and responsive, but the fragments of the pentaray nav high-density mapping eco catheter spline still remained in the left ventricle.The bwi product analysis lab received the device for evaluation on 07-mar-2024.The device evaluation was completed on 07-mar-2024.The device was returned to biosense webster (bwi) for evaluation.Visual inspection of the returned device were performed following bwi procedures.Visual inspection was performed, and one spline was observed detached from the tip leaving internal components exposed.This is related to user error as the pentaray catheter was used in a patient with a prosthetic valve despite it being a contraindication in the instructions for use (ifu).A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The customer complaint was confirmed, the root cause of the adverse event is related to the usage of the device with a patient with mechanical mitral valve.The instructions for use contain (ifu) the following recommendations: do not use the pentaray catheters in patients with prosthetic valves.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi's quality system.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

The investigation was completed on 26-jan-2024.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device number lot 31162130l and no internal actions 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: 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: 18532061
• MDR Text Key: 333087304
• Report Number: 2029046-2024-00207
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835012255
• UDI-Public: 10846835012255
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K123837
• 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,Followup
• Report Date: 03/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D128211
• Device Lot Number: 31162130L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2023
• 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: NGEN RF GENERATOR.; UNK_CARTO 3.
• Patient Outcome(s): Other