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

Model Number D128208

Device Problems Break (1069); Entrapment of Device (1212); Patient Device Interaction Problem (4001)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/28/2022

Event Type  Injury  

Event Description

It was reported that a 60-year-old female patient with a date of birth of (b)(6) 1962 underwent an atrial flutter left (l-afl) ablation procedure with a pentaray nav high-density mapping eco catheter.The pentaray nav high-density mapping eco catheter was caught on the patient's mechanical prosthetic mitral valve and the distal portion of one of the splines detached inside the patient.It was reported that during the procedure, the physician noticed on fluoroscopy that one spline of the pentaray nav high-density mapping eco catheter was caught on the patient's mechanical prosthetic mitral valve apparatus.The physician was aware of the contraindications.The physician was also able to feel that the pentaray nav high-density mapping eco catheter was caught on the mitral valve.When the physician attempted to withdraw the catheter to free it from the mitral valve, the distal portion of one of the splines became disconnected.It was reported that when the catheter was removed from the patient, it was discovered that two electrodes were missing from one of the splines of the catheter.Fluoroscopy confirmed that the disconnected piece of the spline had migrated to the spleen.The dislodged portion of the spline was a single piece.Interventional radiology was monitoring the issue and a follow-up ct scan was ordered.Interventional radiology team was able to locate the device in a distal renal artery and no further intervention was recommended.The patient was reported to be in stable condition.The procedure was able to be completed.Additional information was received.This adverse event was discovered during use of biosense webster products.The physician¿s opinion on the cause of this adverse event is that it was due to the patient¿s condition (prosthetic valve).Intervention provided was monitoring of vital signs and standard procedure recovery monitoring.The patient outcome of the adverse event is fully recovered (no residual effects).The patient did not require extended hospitalization because of the adverse event.Relevant tests and laboratory data include abdominal ct scan post procedure.The medical device entrapment with no excessive manipulation required was assessed as not mdr reportable.The device was removed without surgical intervention, or without using a different device.The potential risk that it could cause or contribute to a serious injury or death to the operator or patient was remote.The broken tip issue was assessed as a mdr reportable malfunction.The foreign body event was assessed as 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.

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

Manufacturer Narrative

The investigation was completed on 03-mar-2023.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 30836696l 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 ; MX
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 15678260
• MDR Text Key: 302470194
• Report Number: 2029046-2022-02654
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835012224
• UDI-Public: 10846835012224
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/03/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: D128208
• Device Catalogue Number: D128208
• Device Lot Number: 30836696L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2022
• Initial Date FDA Received: 10/27/2022
• Supplement Dates Manufacturer Received: 03/03/2023
• Supplement Dates FDA Received: 03/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2022
• 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
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Sex: Female