MAUDE Adverse Event Report: BIOSENSE WEBSTER INC CELSIUS¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Catalog Number UNK_CELSIUS THERMOCOOL

Device Problems Device-Device Incompatibility (2919); Material Twisted/Bent (2981); Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 08/26/2022

Event Type  Injury  

Manufacturer Narrative

Additional information received indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.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 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 female patient born on (b)(6) 1964 (54.4kg) underwent a left lateral accessory pathway ablation procedure with an unknown celsius¿ thermo-cool¿ electrophysiology catheter.The patient suffered cardiac tamponade requiring a pericardiocentesis.During a left lateral accessory pathway procedure, a cardiac perforation occurred.The physician was unable to say which of the ablation catheters caused the perforation and after further consideration he thought he likely perforated the left atrial appendage whilst crossing the mitral valve but could not be sure which of the four catheters he was using at the time.Four different ablation catheters were used via the retrograde approach as stability proved to be challenging.Crossing the mitral valve required a degree of force.The ablation lesions that were placed lasted less than ten seconds each because stability was an issue.A biosense webster d curve celsius catheter was tried which also met some resistance when attempting the retrograde approach and similarly had the same distal tip bend.The patient's blood pressure then dropped to 65/45.For clarification no transseptal puncture had taken place at this time.Though limited ablation was delivered the physician stated this was not the cause of the low blood pressure.The perforation was confirmed with a transthoracic echo and ice and required a pericardiocentesis.After withdrawing 30cc of fluid the patient¿s blood pressure stabilized.The patient was admitted into the intensive care unit (icu) for observation and was stable.Additional information was received.This adverse event was discovered after use of the ablation catheter.The physician¿s opinion on the cause of this adverse event is that multiple ablation catheters were used, and the reach was difficult.Pericardial tap was done.The patient outcome of the adverse event is fully recovered.The patient stayed in the hospital for additional days to have the ep procedure repeated.A transseptal puncture was not performed.The event occurred during the ablation phase.Correct catheter settings were selected on the generator.Additional attempts have been made to obtain clarification to this complaint.However, no further information has been made available.Since the adverse 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.The bent tip issue was assessed as not mdr reportable.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote.The resistance with sheath issue was assessed as not mdr reportable.Interference or friction between devices is a known occurrence.If resistance is encountered, the system may be withdrawn as a unit.This is a common practice during procedures.Since the vast majority of ep procedures utilize multiple device exchanges, an increased potential for patient injury was remote.

Manufacturer Narrative

Additional information was received on 27-sep-2022.These other ablation catheters were not biosense webster, inc.Products.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: CELSIUS¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• 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 ; MX
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15507340
• MDR Text Key: 300877514
• Report Number: 2029046-2022-02340
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_CELSIUS THERMOCOOL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: UNKNOWN BRAND ABLATION CATHETER; UNKNOWN BRAND ABLATION CATHETER; UNKNOWN BRAND ABLATION CATHETER; UNKNOWN BRAND GENERATOR
• Patient Outcome(s): Required Intervention; Life Threatening; Hospitalization
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 54 KG