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

Model Number D128211

Device Problems Entrapment of Device (1212); Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001)

Patient Problems Stroke/CVA (1770); Foreign Body In Patient (2687); Thrombosis/Thrombus (4440)

Event Date 01/11/2022

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Initial reporter phone: (b)(6).Manufacturer's ref.# (b)(4).

Event Description

It was reported that a male patient underwent a cardiac ablation procedure with a pentaray nav high-density mapping eco catheter and the patient suffered a cerebrovascular accident (cva), thrombus requiring surgical intervention and prolonged hospitalization.A pentaray nav high-density mapping eco catheter was used during procedure to perform ablation in a patient with prosthetic valve(s).This occurred after the catheter was inserted.The prosthetic valve become entangled with the pentaray nav high-density mapping eco.Manipulation of the pentaray nav high-density mapping eco back to the sheath resulted in the pentaray nav high-density mapping eco body being removed, but 2 tips of 1 spine were cut ¿1000¿ and remained on the prosthetic valve total detachment.They planned to perform surgical operation after explaining it to the patient's family.The physician commented that they were unaware/didn¿t know that it was contraindicated.The physician commented that thrombus was confirmed after the incident and magnetic resonance imaging (mri) was taken.Extracerebral surgery was performed because the physician confirmed that the thrombus had flowed to the brain.Although the thrombus was removed, the chordae tendineae or papillary muscles seemed to have flowed to the brain (because cardiac tissue was found in the brain according to the doctor), and consequently cerebral infarction occurred.It was reported that when the piece of meat (this is being interpreted to be cardiac tissue) was removed, the blood was smooth, so the bleeding did not stop, and the brain was removed nearly half to prevent brain damage due to blood pressure.On (b)(6) 2022, the patient was transferred to the intensive care unit (icu) and was unconscious around 16: 00.The doctor informed that the operation for hemostasis was about to be completed because of severe bleeding.It said that the brain operation would come first, and that extracardiac surgery such as valve reconstructive surgery would not yet be reached.Additional information received indicated the physician¿s opinion on the cause of this adverse event is that it was the procedure related.The patient¿s outcome of the adverse event was reported as unchanged.One of the pentaray nav high-density mapping eco catheter spines had torn and left near the prosthetic valve.Subsequently, thrombus was confirmed, and cerebral infarction was confirmed by mri, and surgical treatment was performed.During the surgery, it was confirmed that a piece of tissue, not a thrombus, had occluded the cerebral vessels, and the piece of tissue was removed.However, the bleeding did not stop because of the anticoagulant agent being administered, and the brain was removed nearly half to prevent brain damage due to blood pressure.The patient required extended hospitalization.The patient is being followed in the icu and had not yet regained consciousness as of (b)(6) 2022.There was no significant medical history.The damage did not result in wires and/or braid being exposed.The damage did not result in any lifted or sharp rings.The fragments of the pentaray nav high-density mapping eco catheter remain in the patient.Reporter states that they did not receive the details of the sheath but it was another company's sheath.

Manufacturer Narrative

On 17-feb-2022, 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.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 male patient underwent a cardiac ablation procedure with a pentaray nav high-density mapping eco catheter and the patient suffered a cerebrovascular accident (cva), thrombus requiring surgical intervention and prolonged hospitalization.A pentaray nav high-density mapping eco catheter was used during procedure to perform ablation in a patient with prosthetic valve(s).This occurred after the catheter was inserted.The prosthetic valve become entangled with the pentaray nav high-density mapping eco.Manipulation of the pentaray nav high-density mapping eco back to the sheath resulted in the pentaray nav high-density mapping eco body being removed, but 2 tips of 1 spine were cut ¿1000¿ and remained on the prosthetic valve total detachment.They planned to perform surgical operation after explaining it to the patient's family.The physician commented that they were unaware/didn't know that it was contraindicated.Device evaluation details: the product was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.Bwi conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that a spline was detached on the pentaray nav eco catheter.All units are inspected prior to leaving the facility as there are functional tests and inspections at control points based on the process flow diagram (pfd) per its part number to avoid this type of damage from leaving the facility.The damage reported by the customer could be related to the introduction of the catheter into the sheath however, this cannot be conclusively determined.According to the ifu, the device was used without following the instruction.The instructions for use contain the following recommendations: do not introduce the pentaray® nav catheter into a guiding sheath with its distal spines folded backward (i.E., toward the handle).Collapse the spines together using the insertion tube prior to insertion.Do not use the pentaray® nav catheter in conjunction with transseptal sheaths featuring side holes larger than 1.25 mm in diameter.Do not use excessive force to advance or withdraw the catheter through the guiding sheath when resistance is encountered.This catheter is recommended for use with an 8f guiding sheath as the distal spines may be damaged if used with a sheath that is not compatible.Do not use the catheter in patients with prosthetic valves.This patient population is subject to increased risk of embolization of components and resultant patient sequelae.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint condition were identified.As part of bwi¿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: 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13471778
• MDR Text Key: 285351122
• Report Number: 2029046-2022-00234
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835012255
• UDI-Public: 10846835012255
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K123837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D128211
• Device Catalogue Number: D128211
• Device Lot Number: 30659759L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2021
• 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: NON-BWI SHEATH
• Patient Outcome(s): Required Intervention; Hospitalization; Life Threatening
• Patient Sex: Male