MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THMCL SMTCH SF BID, TC, D-D; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D134801

Device Problems Temperature Problem (3022); Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 03/07/2022

Event Type  Injury  

Manufacturer Narrative

Initial reporter phone: (b)(6).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 (b)(6) female patient ((b)(6) kgs, 158 cm) underwent a cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade requiring surgical intervention and prolonged hospitalization.It was reported that two hours after ablation was started, the patient¿s blood pressure decreased, and pericardial drainage was performed, but blood pressure did not return to normal.The patient was moved to the operating room with the state that the percutaneous cardiopulmonary support (pcps) turned around and emergency thoracotomy was performed.The physician commented that the cause was that, at the timing of conducting ablation on the lpv's edge, ablation was conducted at the same place many times.It was an anatomically difficult to approach.A steam pop occurred during ablation.Temperature was not displayed.The adverse event was discovered during use of biosense webster products.The physician¿s opinion on the cause of this adverse event is that it was procedure related.Before the cardiac tamponade was noticed, ablation was performed.Atrial septal puncture was performed with the rf needle.The irrigation catheter flow was set to default setting.Force visualization feature used was dashboard.Color options used prospectively were tag index.Successful hemostasis of tamponade by emergency thoracotomy, blood pressure recovered.The patient was subsequently admitted to the hospital for several days and was discharged after confirming that there were no problems.No ablation was performed above the temperature cut-off and the ablation could be stopped with the stop button or foot pedal release.It was also reported that the soundstar dial to perform the deflection was idling only in the anterior direction and the deflection was not able to be conducted.The soundstar was replaced.The deflection issue with the soundstar catheter was assessed as not mdr reportable.The most likely consequence is an intraprocedural delay.The potential risk that it could cause or contribute to a serious injury or death is remote.Since the event (cardiac tamponade) is life threatening and it might result in a 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 no temperature and steam pop issues were assessed as not mdr reportable.The ablation cannot be performed since there is no radiofrequency (rf) energy applied.The most likely consequence is an intraprocedural delay.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.Steam pop is not considered to be a device malfunction.Steam pop is an expected physiological phenomenon.

Manufacturer Narrative

On 04-apr-2022, 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.Additional information was received on 14-apr-2022 and it was reported that the correct lot number for this reported event is 30676566l.Therefore, the d4.Lot, d4.Expiration date, and h4.Device manufacture date have been updated.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

Additional information was received on 6-may-2022.This adverse event was discovered during use or post use of biosense webster products.The physician¿s opinion on the cause of this adverse event is that it was patient condition.Drainage and emergency thoracotomy was performed the patient outcome of the adverse event is fully recovered.The patient was hospitalized for several days due to thoracotomy.Relevant test, lab data, and patient history could not be obtained from the physician.The event occurred when pvi was checked after ablation.Correct catheter settings were selected on the generator.Stsf temperatures were no longer displayed during the procedure.Dashboard force visualization features was used.The visitag module was used, the parameters for stability used 3mm,3sec,25%,3g, 2mm tag.No additional filter was used with the visitag.Tag index color option was used prospectively.The device evaluation was completed on 26-apr-2022.It was reported that a 76-year-old female patient (60 kgs, 158 cm) underwent a cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade requiring surgical intervention and prolonged hospitalization.It was reported that two hours after ablation was started, the patient¿s blood pressure decreased, and pericardial drainage was performed, but blood pressure did not return to normal.The patient was moved to the operating room with the state that the percutaneous cardiopulmonary support (pcps) turned around and emergency thoracotomy was performed.The physician commented that the cause was that, at the timing of conducting ablation on the lpv's edge, ablation was conducted at the same place many times.It was an anatomically difficult to approach.A steam pop occurred during ablation.Temperature was not displayed.Device evaluation details: the product was returned to biosense webster for evaluation.A visual inspection and an evaluation of all features of the device were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.Per the event, several tests were performed.The magnetic passed the test but, temperature and force features were not tested completely since, no temperature was displayed due to an open circuit on the tip area, only impedance was visualized.In addition, the product was deflecting and irrigating correctly, and no malfunctions were observed.A manufacturing record evaluation was performed for the finished device 30681167l number, and no internal actions related to the complaint were found during the review.The temperature issue reported by the customer was confirmed; however, the root cause of the adverse event remains unknown.There may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.The ifu (instruction for use) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation, or tamponade.With the available information, the investigation results cannot be related to the adverse reported by the customer in addition, the physician commented that the cause was that at the timing that conducting ablation on the lpv's edge, ablation was conducted at the same place many times, ablation was conducted on because it was anatomically difficult to approach." the instructions for use contain the following warning stated in the carto 3 system manual: if the rf generator does not display temperature, verify that the appropriate cable is plugged into the rf generator.As part of biosensor webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Explanation of codes: investigation findings: no device problem found (c19) / investigation conclusions: no problem detected (d14) were selected as related to the adverse event.Investigation findings: open circuit (c0205) / investigation conclusions: cause not established (d15) / component code: electrical lead/wire (g02015) were selected as related to the open circuit on the tip area.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: THMCL SMTCH SF BID, TC, D-D
• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 6465917981
• MDR Report Key: 13996276
• MDR Text Key: 288502058
• Report Number: 2029046-2022-00718
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010145
• UDI-Public: 10846835010145
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/20/2022

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2022
• Device Model Number: D134801
• Device Catalogue Number: D134801
• Device Lot Number: 30676566L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2022
• Initial Date FDA Received: 04/04/2022
• Supplement Dates Manufacturer Received: 04/04/2022; 04/26/2022
• Supplement Dates FDA Received: 04/18/2022; 05/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2021
• 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: SMARTABLATE GEN. KIT (JAPAN); SOUNDSTAR ECO SMS 8F CATHETER; UNK BRAND CATHETER; UNK BRAND CATHETER; UNK BRAND RF NEEDLE; UNK_CARTO 3
• Patient Outcome(s): Life Threatening; Required Intervention; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 60 KG