MAUDE Adverse Event Report: BIOSENSE WEBSTER INC OCTARAY, GALAXY, 48P, 2-5-2-5-2, D-CURVE; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY

Model Number D160902

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

Patient Problem Rupture (2208)

Event Date 07/19/2022

Event Type  Injury  

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

Event Description

It was reported that a patient underwent an idiopathic ventricular tachycardia ¿ right (idvt) ablation procedure with an octaray, galaxy, 48p, 2-5-2-5-2, d-curve and suffered a chordae tendineae being removed from the patient.The catheter was entrapped and there was a 30-minute delay in a vt case.When trying to introduce the octaray catheter into the right ventricle, the deflection curve was too short (d), it could only get to the tricuspid annulus.The physician then tried to force the catheter to get into the ventricle, rotating and forcing it several times.At some point, he detected the catheter was stuck, so he pulled out the catheter.He could release the catheter; however, when it was already outside the patient, he saw, what was trapped between the legs of the catheter, was one chordae tendineae.The procedure was successfully completed with a 30-minute delay.An echocardiogram was performed after the procedure, and the functionality of the tricuspid annulus was not compromised.Fragments were generated and they were removed easily without additional intervention.This event was assessed as a papillary muscle rupture because the chordae tendineae are strong, fibrous connections between the valve leaflets and the papillary muscles.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.This adverse event was discovered during use of biosense webster products.The physician¿s opinion on the cause of this adverse is that it was due to the procedure.A device with a curve that was too short was selected (d) to get into the right ventricle, and the physician had to force it.The patient outcome of the adverse event is fully recovered with no residual effects.The patient did not require extended hospitalization because of the adverse event.A smartablate system was used and it was reported as not related with the event.

Manufacturer Narrative

A picture was received for evaluation on 19-jul-2022, following biosense webster's procedures.It was reported that a patient underwent an idiopathic ventricular tachycardia ¿ right (idvt) ablation procedure with an octaray, galaxy, 48p, 2-5-2-5-2, d-curve and suffered a chordae tendineae being removed from the patient.The catheter was entrapped and there was a 30-minute delay in a vt case.Photo evaluation details: according to the pictures provided by the customer, the splines were observed in a knot condition, due to a chordae tendineae being observed stuck between the splines.The knot condition could be related to an excessive force applied to the device during the procedure, since according to the information provided, force on the catheter was applied to get into the ventricle, rotating and forcing it several times.A manufacturing record evaluation was performed for the finished device number 30790274l and no internal action related to the complaint was found during the review.The customer complaint was confirmed from the photo analysis.However, the device has not been returned for evaluation.Since no device has been received, no product investigation can be performed.If the device is received in the future, the product analysis will be performed as appropriate in order to find the root cause of the complaint.H6.Investigation findings code of "appropriate term/code not available" represents photo/video analysis.Explanation of codes: investigation findings: operational problem identified (c13) / investigation conclusions: unintended use error caused or contributed to event (d1102) were selected as related to the biological material found on the device.Investigation findings: no findings available (c20) / investigation conclusions: cause not established (d15) / were selected as related to the device that has not been returned for evaluation.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number:(b)(4) during an internal review on 17-aug-2022, it was noted that a photo was received on 19-jul-2022; however, this information was inadvertently excluded from the initial report (b)(4).This report includes the receipt date for the photo, as well as the evaluation details of the photo received.

Manufacturer Narrative

The biosense webster inc.(bwi) product analysis lab received the device for evaluation on 28-sep-2022.The device evaluation was completed on 17-oct-2022.It was reported that a patient underwent an idiopathic ventricular tachycardia ¿ right (idvt) ablation procedure with an octaray, galaxy, 48p, 2-5-2-5-2, d-curve and suffered a chordae tendineae being removed from the patient.The catheter was entrapped and there was a 30-minute delay in a vt case.Device evaluation details: bwi conducted a visual inspection and an evaluation of all features of the catheter.Visual analysis of the returned product revealed that no damage or anomalies were observed.Per the event, several tests were performed.The magnetic features were tested, and no issues were observed.In addition, the product was deflecting and irrigating correctly, a dimensional test was performed, and the outer diameters of the device were found within specifications.No malfunctions were observed during the product analysis.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.No malfunction was observed during the product analysis.The instructions for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation, or tamponade.The root cause of the adverse event remains unknown, no conditions were observed on the catheter that could contribute to the adverse event.There may have been other circumstances or issues that occurred during the use of the catheter that could not be replicated during the analysis.As part of bwi¿s quality process all catheters 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: OCTARAY, GALAXY, 48P, 2-5-2-5-2, D-CURVE
• 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: 15234038
• MDR Text Key: 297977127
• Report Number: 2029046-2022-01887
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835021110
• UDI-Public: 10846835021110
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K193237
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/25/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 04/11/2023
• Device Model Number: D160902
• Device Catalogue Number: D160902
• Device Lot Number: 30790274L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/19/2022
• Initial Date FDA Received: 08/16/2022
• Supplement Dates Manufacturer Received: 07/19/2022; 09/28/2022
• Supplement Dates FDA Received: 08/17/2022; 10/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2022
• 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_SMARTABLATE GENERATOR
• Patient Outcome(s): Required Intervention; Life Threatening