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

Model Number D134801

Device Problems High Readings (2459); Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 09/14/2022

Event Type  Injury  

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 number 30791860l and no internal actions related to the complaint was found during the review.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.Initial reporter phone: (b)(6).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a 79-year-old female patient underwent a cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient suffered cardiac tamponade requiring pericardiocentesis.In the premature ventricular contraction (pvc) of right ventricular outflow tract (rvot) origin, it was difficult to advance the thermocool® smart touch® sf bi-directional navigation catheter to the rvot without getting up after hitting the anterior wall of the right ventricle.As the place was close to the origin of pvc when thermocool® smart touch® sf bi-directional navigation catheter rose a little higher and ablation was conducted at 35w.However, the ablation was immediately stopped (2 times) since impedance spike happened beyond cut off (40 o).The physician instructed to turn off the setting, and ablation was conducted once.At that time, the patient felt a chest pain.Therefore, the fluoroscopy was used and confirmed heart shadow was slow.Transthoracic echocardiography showed some effusion in the anterior wall of the right ventricle.Since blood pressure was under 100, pericardial drainage was performed.The physician's opinions on the relationship between the event and the product is that the perforation was probably due to elevation of the thermocool® smart touch® sf bi-directional navigation catheter from the anterior right ventricular wall.There were no abnormalities observed prior to use or during use of the product.Additionally, the physician pointed out that the dilator movement was not smooth when the carto vizigo¿ 8.5f bi-directional guiding sheath - medium was inserted after puncture.So, the physician requested replacement of the sheath.The same curve one was not found in the hospital, and the physician approved carto vizigo¿ 8.5f bi-directional guiding sheath - small as a replacement product.The physician pointed out that the rotary knob of the carto vizigo¿ 8.5f bi-directional guiding sheath - small handle was stiffer than usual, so the carto vizigo¿ 8.5f bi-directional guiding sheath - small was not used.Sl-0 sheath was selected, and the procedure was continued.These issues occurred when the sheath was advanced after puncture.The physician¿s opinion on the cause of this adverse event is that it was procedure related.There was no evidence of steam pop.No error messages were observed on biosense webster equipment during the procedure.Dashboard and vector force visualization features were used.Tag index color option was used prospectively.The resistance felt did not result in any damage to the sheath.There was resistance when the dilator was put into the sheath.The resistance did not result in any damage to dilator/catheter.High force was felt between the sheath and the dilator and high resistance.There was no occlusion when irrigating the sheath.The patient outcome of the adverse event was fully recovered.The patient was admitted to the intensive care unit (icu) for precaution after the procedure but returned to the general ward within the same day.The drain was removed on the next day, and the patient recovered.A smartablate generator was used during this case.No transseptal puncture performed.The irrigated catheter was used in the event and flow setting were pre rf time: 2sec, post rf time: 2sec, ~30w ablation: 8ml/min, 31~50w ablation: 15ml.The pump was switching from low to high flow during ablation.The visitag module parameters for stability were set at range 3mm, time 3sec, fot 25%/3g, tag size 2mm.No additional filter used.Resistance did not result in any damage to the sheath or dilator.There was resistance when they were trying to put the dilator into the sheath.High force was felt between the sheath and the dilator.There was no occlusion when irrigating the sheath.The customer¿s reported issues of resistance and stiffness with the carto vizigo¿ 8.5f bi-directional guiding sheaths are not considered to be mdr reportable since an increased potential for patient injury is remote.The customer¿s reported high impedance/force is not mdr reportable since the user-defined cut-off was exceeded and ablation was stopped the potential that it could cause or contribute to a death, serious injury, or other significant adverse event, is remote.

• Brand Name: THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15594891
• MDR Text Key: 301644815
• Report Number: 2029046-2022-02510
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D134801
• Device Catalogue Number: D134801
• Device Lot Number: 30791860L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2022
• 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: 8.5F SHEATH WITH CURVE VIZ MDC; 8.5F SHEATH WITH CURVE VIZ SMC; CARTO 3 SYSTEM; SMARTABLATE GEN. KIT (JAPAN); UNKNOWN PUMP; UNSPECIFIED SL-0 SHEATH
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 79 YR
• Patient Sex: Female