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

Model Number	D128210
Medical Device Problem Codes	Break (1069); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an unknown patient underwent an atrial flutter left (l-afl) ablation procedure with a pentaray nav high-density mapping eco catheter.The patient suffered a foreign body due spline being stripped off by the mechanical valve.It was reported that while mapping in the left atrium, near the left atrial appendage that they pulled the catheter back and the catheter became wedged in the mechanical valve.When they tried to pull out the catheter part of the electrode on the spline of the pentaray catheter was stripped off by the mechanical valve.The patient was stable went they left the procedure room.The patient has a mechanical mitral valve and the doctor was advised and was also informed of the contraindications of the use of the pentaray catheter.Broken tip is mdr-reportable.Since the event is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr-reportable.
Additional Manufacturer Narrative
The bwi product analysis lab received the device for evaluation.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 4.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.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
The product investigation was completed on 20-oct-2022.It was reported that a male patient in their late 50¿s to early 60¿s underwent an atrial flutter left (l-afl) ablation procedure with a pentaray nav high-density mapping eco catheter.The patient suffered a foreign body due spline being stripped off by the mechanical valve.Device evaluation details: visual analysis revealed that the splines and electrodes were detached with internal parts exposed, the root cause of the adverse event could be related to the usage of the catheter with a patient with a mechanical valve.A manufacturing record evaluation was performed for the finished device 30831522l number, and no internal actions related to the complaint were found during the review.The customer complaint regarding spline damage was confirmed.The root cause of the adverse event could be related to the usage of the catheter with a patient with a mechanical valve.There may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.The ifu (instruction for use) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation, or tamponade.Do not use pentaray catheters in patients with prosthetic valves.A relative contraindication for cardiac catheter procedures is an active systemic infection.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).On 19-oct-2022, it was identified that details were mistakenly omitted from the initial report.The details are as follows: the patient is a male in their late 50s to early 60s.The adverse event was discovered during the procedure.In the physician¿s opinion, the reason for the adverse event was the patient condition (mechanical mitral valve).The device became entrapped in one of the leaflets causing the device and the valve to fail.No surgery was required but they had to snare the electrodes that were stuck in the mva that had inadvertently shut half of the mva off from contracting.Once the electrodes were snared, one electrode did pop off during that time and it became wedged in the dao and was not retrieved due them not wanting to cause more harm than good.The patient has fully recovered and is doing much better with no problems from the event occurring the patient did not require extended hospitalization because of the adverse event.Other than the normal monitoring session, they were not required to stay longer than usual.Other relevant history includes mva repair and replacement with a mechanical valve.The damage did result in wires being exposed.The damage resulted in lifted or sharp rings.There was no resistance or difficulty during insertion or removal of the catheter.The catheter was not pre-shaped.An sl0 8.5f 71 cm sheath was used.

• Brand Name: PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER
• Common Device Name: 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-7981
• MDR Report Key: 15613509
• Report Number: 2029046-2022-02557
• Device Sequence Number: 5983256
• Product Code: MTD
• UDI-Device Identifier: 10846835012248
• UDI-Public: 10846835012248
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K123837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/03/2025
• Device Model Number: D128210
• Device Catalogue Number: D128210
• Device Lot Number: 30831522L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2022
• Supplement Date Received by Manufacturer: 10/19/2022
• Initial Report FDA Received Date: 10/17/2022
• Supplement Report FDA Received Date: 11/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SL0 8.5F 71 CM
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Sex: Male