MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SF BI-DIRECTIONAL CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number BDI35DFRT

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Cardiac Tamponade (2226); Thrombosis/Thrombus (4440)

Event Date 12/06/2021

Event Type  Injury  

Event Description

It was reported that a patient underwent a cardiac ablation procedure with a thermocool® sf bi-directional catheter and the patient had thrombosis and cardiac tamponade requiring pericardiocentesis and surgical intervention.It was reported that tamponade occurred in a procedure with paroxysmal supraventricular tachycardia (psvt) which had been conventionally performed since around 19:00 on dec.6.Although drainage was conducted, the condition did not improve, and thrombus was pulled in.Because the site of bleeding was unknown, surgery for heart-lung machine placement by midline incision was performed.After operation from around 11:00 on dec.6 to around 5:00 on the following day, the patient is currently being followed up in intensive care unit (icu).Thoracotomy was performed.Blood was observed in the left ventricular posterior wall, and treatment with hemostat was performed.Bleeding was not from a single point, but a finding that slowly bleeds from the entire area.Additional information received indicated extubation was scheduled to be performed (b)(6) 2021.Although renal function decreased was noted, it was confirmed by contrast enhanced computed tomography (ct) that hemorrhage had ceased.The patient awakens, continue to monitor the progress after blood pressure recovery.The background that led to tamponade was as follows; although the celsius c curve is issued, the catheter did not reach the ablation area, and thermocool® sf bi-directional catheter with a different diameter of curve was released, and when it was approached the left ventricle (lv) retrogradely, there was a feeling of strong contact with the lateral side.After the procedure, when we reviewed the fluoroscopic image, heard that there was a finding that the cardiac contraction had worsened after making contact.The attending physician as well as the dr who was present at the operating room confirmed that there was no causal relationship with the product.Contrast-enhanced ct confirmed cessation of hemorrhage.

Manufacturer Narrative

Device investigation details: the device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances related to the complaint was found during the review.(b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(4).

Manufacturer Narrative

On 14-jan-2022, biosense webster inc.Received additional information about the patient and the event.It was reported the patient¿s outcome from the adverse event is improved.The physician considered the ae to be unrelated to bwi product, but made no additional comments.The event is believed to have happened during the mapping phase of the procedure.There were no error messages observed on biosense webster equipment during the procedure.There was no evident of steam pop.A smartablate generator was used in the procedure.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Manufacturer Narrative

Manufacturer's ref # (b)(4) on(b)(6)-2022, it was noticed that "unk_preface sheath" was incorrectly reported as a concomitant device in field "d10.Concomitant medical products and therapy dates".There is no indication that a preface sheath was used during this case, as such, please remove/consider it removed from field d10.Concomitant medical products and therapy dates.

• Brand Name: THERMOCOOL® SF BI-DIRECTIONAL CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13122270
• MDR Text Key: 286591589
• Report Number: 2029046-2021-02279
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835002812
• UDI-Public: 10846835002812
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030031/S025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/21/2022
• Device Model Number: BDI35DFRT
• Device Catalogue Number: BDI35DFRT
• Device Lot Number: 30274860L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2019
• 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: BUNDLE-CELSIUS 4MM-D7TCCL252RT-000063; UNK_PREFACE SHEATH; UNK_SMARTABLATE GENERATOR
• Patient Outcome(s): Required Intervention; Life Threatening; Hospitalization