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 Material Integrity Problem (2978); Patient Device Interaction Problem (4001)

Patient Problem Air Embolism (1697)

Event Date 05/03/2022

Event Type  Injury  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a pentaray nav high-density mapping eco catheter.Air was introduced into the patient.It was reported that there were bubbles displayed on ultrasound when the pentaray was advanced into the left atrium.When the plunger on the handle was advanced for catheter deflection, it kinked the irrigation tubing which correlated with the bubbles seen on the ultrasound image.The kinked tube noted by the doctor was the tube used for irrigation and it moved in and out of the handle with unidirectional deflection.The doctor noted bubbles on the intracardiac echocardiography (ice) image of the left atrium (la) when the pentaray was inserted.The catheter was replaced per physician¿s request, and the issue was resolved.The procedure was completed successfully and without issue.There were no patient consequences.The catheter is available for return.Since the event (air embolism) 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.The luer hub issue was assessed as not mdr reportable.Since the operator would not be able to connect the tubing set to the catheter, the operator will have to replace the device.The most likely consequence is an intraprocedural delay.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.

Manufacturer Narrative

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

Manufacturer Narrative

The biosense webster inc.(bwi) product analysis lab received the device for evaluation on 31-may-2022.The device evaluation was completed on 07-jun-2022.It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a pentaray nav high-density mapping eco catheter.Air was introduced into the patient.It was reported that there were bubbles displayed on ultrasound when the pentaray was advanced into the left atrium.When the plunger on the handle was advanced for catheter deflection, it kinked the irrigation tubing which correlated with the bubbles seen on the ultrasound image.The kinked tube noted by the doctor was the tube used for irrigation and it moved in and out of the handle with unidirectional deflection.The doctor noted bubbles on the intracardiac echocardiography (ice) image of the left atrium (la) when the pentaray was inserted.The catheter was replaced per physician¿s request, and the issue was resolved.The procedure was completed successfully and without issue.There were no patient consequences.Device evaluation details: the product was returned to biosense webster inc.(bwi) for evaluation.A visual inspection and an evaluation of all features of the device were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.Per the event, several tests were performed.The magnetic and electrical features were tested, and no issues were observed.In addition, the product was deflecting and irrigating correctly.No malfunctions were observed during the product analysis.A manufacturing record evaluation was performed for the finished device 30756002l number, and no internal actions related to the complaint were found during the review.No malfunction was observed during the product analysis.The root cause of the adverse event remains unknown.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.The root cause of the adverse event remains unknown.As part of biosense webster¿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 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14519718
• MDR Text Key: 293278850
• Report Number: 2029046-2022-01144
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835012255
• UDI-Public: 10846835012255
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 06/27/2022

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?: No
• Device Operator: Health Professional
• Device Model Number: D128211
• Device Catalogue Number: D128211
• Device Lot Number: 30756002L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/03/2022
• Initial Date FDA Received: 05/26/2022
• Supplement Dates Manufacturer Received: 05/31/2022
• Supplement Dates FDA Received: 06/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2022
• 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: UNK BRAND CATHETER.
• Patient Outcome(s): Life Threatening