MAUDE Adverse Event Report: BIOSENSE WEBSTER INC OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Catalog Number D140901

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

Patient Problem Perforation of Vessels (2135)

Event Date 07/06/2023

Event Type  Injury  

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 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: (b)(4).

Event Description

It was reported that a patient underwent an idiopathic ventricular tachycardia (idvt) ablation procedure with an optrell mapping catheter with true ref technology.It was reported that during an idiopathic vt case, a perforation to the iliac artery was noticed in the patient.The physician had difficulty getting access arterially and venously in the groin area.The physician was finally able to get venous access, but when the physician had advanced the optrell catheter on the arterial side, it was getting "stuck." the contrast dye was shot into the patient.The physician noticed that the contrast dye was not flowing properly.The patient's blood pressure dropped.The patient continued to be monitored and hold pressure.A surgeon was called in, and the patient was taken straight to general surgery.They could not confirm what medical intervention was provided to the patient.The patient was stable at the time of the call.The adverse event was discovered during use of biosense webster products.The physician¿s opinion on the cause of this adverse event was that it was procedure and/or patient condition related.The patient was taken to surgery for repair of the vessel.The outcome of the adverse event was improved.Patient required extended hospitalization because of the adverse event for recovery from repair.Generator information was a smartablate g4c-0749.There was no difficulty experienced while maneuvering the catheter or during the withdrawal.Sheath used was an 8f brand and model unknown.There was no detachment of any component.The issue did not result in exposure of any internal catheter components or sharp edges.Picture or the fluoro image is unavailable.It was also reported that when the keyboard shortcut of shft + e was used to create a zoomed in view of the box of signals, the window of the box was shift to the left, and the biosense webster inc.(bwi) representative could not see any signals in the window of interest.The bwi representative checked and confirmed the setup of the window of interest in the annotation viewer, and it was correct.They tried to adjust the size of the box without resolution.The procedure continued with the issue persisting.The bwi field service engineer (fse) was dispatched to troubleshoot the issue.The issue with the software was assessed as not mdr reportable.The potential risk that it could cause or contribute to a death or serious deterioration in state of health is remote.

Manufacturer Narrative

It was reported that a patient underwent an idiopathic ventricular tachycardia (idvt) ablation procedure with an optrell mapping catheter with true ref technology.It was reported that during an idiopathic vt case, a perforation to the iliac artery was noticed in the patient.The physician had difficulty getting access arterially and venously in the groin area.The physician was finally able to get venous access, but when the physician had advanced the optrell catheter on the arterial side, it was getting "stuck." the contrast dye was shot into the patient.The physician noticed that the contrast dye was not flowing properly.The patient's blood pressure dropped.The patient continued to be monitored and hold pressure.A surgeon was called in, and the patient was taken straight to general surgery.They could not confirm what medical intervention was provided to the patient.The patient was stable at the time of the call.The adverse event was discovered during use of biosense webster products.The physician¿s opinion on the cause of this adverse event was that it was procedure and/or patient condition related.The patient was taken to surgery for repair of the vessel.The outcome of the adverse event was improved.Patient required extended hospitalization because of the adverse event for recovery from repair.Device analysis details: the biosense webster (bwi) product analysis lab received the device for evaluation on 09-aug-2023.Visual inspection, deflection and outer diameter (od) test and revision of all features were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.A deflection test was performed, and the curve was deflecting within specifications.No deflection issues were observed.Outer diameter test was performed, and measurements are within specifications.The other device features were reviewed, and no issues were observed during the product investigation.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint condition were identified.No malfunction was observed during the product analysis.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: OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• 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: 17455514
• MDR Text Key: 320376615
• Report Number: 2029046-2023-01700
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835023015
• UDI-Public: 10846835023015
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K211438
• 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: 09/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/08/2023
• Device Catalogue Number: D140901
• Device Lot Number: 30906320M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2022
• 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: CARTO 3 RMT SYSTEM; SMARTABLATE GENERATOR KIT-US; UNK BRAND 8FR SHEATH
• Patient Outcome(s): Required Intervention; Life Threatening; Hospitalization
• Patient Sex: Female