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 Signal Artifact/Noise (1036); Break (1069); Material Protrusion/Extrusion (2979); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/11/2022

Event Type  malfunction  

Event Description

It was reported that a patient underwent a afib ¿ paroxysmal ablation procedure with an octaray, galaxy, 48p, 2-5-2-5-2, d-curve and an electrode was detached and other electrodes on the spline were damaged.From the beginning of the procedure, it was observed that there were noisy signals on an electrode.The physician did not want to replace the cable nor the catheter.After the case, they saw that one spline was bent/corrugated, that the third electrode of the spline was missing, electrode two was flattened, and that electrode four was also pressed a little flat.An 8 fr sheath was used as per the recommendation.The surgery was not delayed due to the reported event.The patient was monitored when the event occurred.The procedure was successfully completed.It is unknown if the catheter electrode was missing before the procedure.There was no patient consequence at the time of reporting.No other medical intervention was required.Additional information was received (b)(6)2022.No further investigation (ct & mri) was performed to the patient to confirm that the missing electrode was not inside the patient¿s body.No other intervention was performed.The actual patient outcome is without any issue.No difficulty was experienced during the withdrawal from the catheter.During the withdrawal from electrode/fragments, the catheter electrode was missing.It is unknown whether the electrode was already missing prior the procedure.A withdrawal from fragments/electrode did not take place.On (b)(6)2022, a response was received regarding the question on whether the patient has a valve (mitral, mechanical).The response received was that there is no corresponding information available from the customer.The noise issue and spline bent issues are not mdr reportable.The risk to the patient is low.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.The electrode damage was assessed as mdr reportable product malfunction.Electrode ring edges appear to be sharp or rough ¿ which may cause damage to vascular endothelial linings during the withdrawal of the catheter and sheath.The broken tip issue was assessed as mdr reportable product malfunction.Catheter integrity is not maintained, and internal components are exposed to patient.

Manufacturer Narrative

Initial reporter address line 1 (cont.): (b)(6).Investigation findings code of "appropriate term/code not available" represents photo/video analysis.A picture was received for evaluation following biosense webster's procedures.According to pictures provided by the customer, the electrode on one of the splines was detached from its original place, exposed wires were observed on the picture.Also, the spline was observed flattened.The detached condition for the electrode is related to the noise signal reported by the customer.The instructions for use of the catheter indicate in the warnings section: that the catheter is recommended for use with an 8.5f guiding sheath because the distal spines may be damaged if used with a sheath that is not compatible.Also, excessive bending or kinking of the catheter shaft or spines may damage lead wires and cause loss of electrode function.A manufacturing record evaluation was performed for the finished device, and no internal actions related to the reported complaint were identified.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.This report is being submitted pursuant to the provisions of 21 cfr, part 803.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: pc-(b)(4).

Manufacturer Narrative

The biosense webster, inc.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

The device evaluation was completed on 04-jan-2023.It was reported that a patient underwent a afib ¿ paroxysmal ablation procedure with an octaray, galaxy, 48p, 2-5-2-5-2, d-curve and an electrode was detached and other electrodes on the spline were damaged.Device evaluation details: the octaray nav product was returned to biosense webster (bwi) for evaluation.A visual inspection and electrical evaluation of the returned device were performed following bwi procedures.The device was inspected, and it was found that the device was missing electrode 16 with a wire exposed and electrode 15 was bent.An electrical test was performed, and an open circuit was found on the tip area.The root cause of the electrode missing could be related to the sheath used during the procedure.A manufacturing record evaluation was performed for the finished device (b)(6) number, and no internal action was found during the review.The issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.The instructions for use contain (ifu) the following recommendations: the catheter is recommended for use with an 8.5 f guiding sheath because the distal spines may be damaged if used with a sheath that is not compatible.Do not use the catheter in conjunction with a transseptal sheath featuring side holes larger than 1.25 mm in diameter.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi's quality system.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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 15765523
• MDR Text Key: 307210756
• Report Number: 2029046-2022-02788
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835021110
• UDI-Public: 10846835021110
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K193237
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/20/2022
• Device Model Number: D160902
• Device Catalogue Number: D160902
• Device Lot Number: 30672190L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/11/2022
• Initial Date FDA Received: 11/09/2022
• Supplement Dates Manufacturer Received: 11/23/2022; 01/04/2023
• Supplement Dates FDA Received: 12/16/2022; 01/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2021
• 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 8FR SHEATH