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 05/25/2022

Event Type  Injury  

Event Description

It was reported that a male patient underwent an atrial fibrillation (afib) ablation procedure with a pentaray nav high-density mapping eco catheter and the patient suffered foreign bodies in the gluteus artery after one of the splines of the pentaray nav high-density mapping eco catheter got caught in the patient's mechanical valve.It was reported that towards the end of the procedure one of the pentaray nav high-density mapping eco catheter splines got caught in the patient's mechanical valve.When the physician advanced the sheath (unknown brand/model) the sheath sheared off 4 electrodes.The electrodes then jumped into the left ventricle, subsequently traveling into the descending aorta.The physician tried to snare the electrodes but was unsuccessful.The electrodes then advanced to the gluteus artery.The physician felt comfortable leaving the electrodes in their current position.The procedure was then continued, and all arrhythmias were terminated successfully.No further complications were noted during the procedure.The physician dissected one of the pentaray nav high-density mapping eco catheter¿s splines as they wanted to see the internal composition.The caller noted that there is a clear and obvious dissection on the said spline and there are still 3 electrodes attached.The physician¿s opinion on the cause of this adverse event is that it was bwi product malfunction.The tip of the pentaray nav high-density mapping eco catheter spline was caught in a mechanical valve and pulled off the catheter.The patient is in stable condition.The patient outcome of the adverse event is fully recovered with no adverse effects.The patient did not require extended hospitalization because of the adverse event.The damage resulted in wires being exposed and rings were pulled off the catheter.The patient has not exhibited any neurological symptoms since the procedure was completed.Clarification provided for statement that, "the physician dissected one of the pentaray catheter splines as they wanted to see the internal composition" this occurred during the procedure when determining how to proceed.

Manufacturer Narrative

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 ref.# (b)(4).

Manufacturer Narrative

It was reported that a male patient underwent an atrial fibrillation (afib) ablation procedure with a pentaray nav high-density mapping eco catheter and the patient suffered foreign bodies in the gluteus artery after one of the splines of the pentaray nav high-density mapping eco catheter got caught in the patient's mechanical valve.It was reported that towards the end of the procedure one of the pentaray nav high-density mapping eco catheter splines got caught in the patient's mechanical valve.When the physician advanced the sheath (unknown brand/model) the sheath sheared off 4 electrodes.The electrodes then jumped into the left ventricle, subsequently traveling into the descending aorta.The physician tried to snare the electrodes but was unsuccessful.The electrodes then advanced to the gluteus artery.The physician felt comfortable leaving the electrodes in their current position.The procedure was then continued, and all arrhythmias were terminated successfully.No further complications were noted during the procedure.The physician dissected one of the pentaray nav high-density mapping eco catheter¿s splines as they wanted to see the internal composition.The caller noted that there is a clear and obvious dissection on the said spline and there are still 3 electrodes attached.Device investigation details: the device investigation has been completed which included performing a device history record (dhr) evaluation.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.However, if the product is received at a later date, the investigation will be updated as applicable.A device history record evaluation was performed for the finished device 30788648l number, and no internal actions related to the complaint was found during the review.As part of our company quality system process, all devices are manufactured, inspected, and distributed 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14772475
• MDR Text Key: 294486613
• Report Number: 2029046-2022-01400
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/03/2023

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: 30788648L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/25/2022
• Initial Date FDA Received: 06/22/2022
• Supplement Dates Manufacturer Received: 05/03/2023
• Supplement Dates FDA Received: 05/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2022
• 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
• Treatment: SNARE
• Patient Outcome(s): Required Intervention
• Patient Sex: Male