MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D133602

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

Patient Problem Cardiac Tamponade (2226)

Event Date 11/30/2022

Event Type  Injury  

Manufacturer Narrative

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 lot 30800937m and no internal action related to the complaint was found during the review.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

It was reported that an 75-year-old female patient underwent an idvt ablation procedure with a thermocool® smart touch¿ electrophysiology catheter.The patient suffered cardiac tamponade requiring a pericardiocentesis.It was reported that while ablating the rvot free wall pvc anterior side, and after mapping, they were ablating with a standard stf unidirectional ablation catheter.They had found the pvc and ablated it and then decided to ablate a couple more burns at the end.There was an impedance spike that was displayed on the generator and the generator cut off.They burned one more time and while checking with the ice catheter a pericardial effusion was noted.A pericardiocentesis was done and about 300ml of fluid was removed.The drain was left in the patient.The patient did not require surgical repair.The patient was stable when they left the room.The patient is staying overnight for observation.They spoke with the physician and they thought the patient had thin tissue and the adverse event may have occurred during the impedance spike.They used an ice catheter, pentaray f curve, smart touch f ablation catheter, quad johnsons st.Jude medical, and an sr0 competitor sheath from abbott.They used 30 watts for ablations.The catheter was discarded.Physician¿s opinion on the cause of this adverse event was the patient condition ¿ post case physician said she believed due to location on rvot free wall, the patient had thin tissue.The outcome of the adverse event was unknown, patient was stable leaving the procedure room and was going to stay overnight for observation.The patient stayed overnight for observation, but per the physicians normal pvc ablation protocol the patient would have spent the night anyways, so they were not sure if it was extended more than normal generator information was a smart ablate sn: g4c-1411 ref: m490002 hw-rev: 07.Transseptal puncture was not performed.No evidence of steam pop.The flow setting for the irrigated catheter used was standard thermocool f curve; flow rates high: 17¿30ml low flow 2ml.Correct catheter settings was selected on the generator.Pump switching was from ¿low¿ to ¿high¿ flow during ablation.There was high impedance spike during one ablation, generator auto shut off, and error message read high impedance.Force visualization features used were graph, dashboard and visitag.Parameters for stability for the visitag module used was recommended settings: 2, 3, 25% 3g.Additional filter used with the visitag was resp gated.Color options used prospectively was other impedance -scale was 0-10 ohms.High impedance is not mdr-reportable.Since the 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.

• Brand Name: THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16018998
• MDR Text Key: 305874680
• Report Number: 2029046-2022-03209
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D133602
• Device Catalogue Number: D133602
• Device Lot Number: 30800937M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2022
• 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 SYSTEM; CARTO VISITAG MODULE; ICE CATHETER; PENTARAY F CURVE; QUAD JOHNSONS ST. JUDE MEDICAL; SMARTABLATE GENERATOR; SR0 ABBOTT SHEATH
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 75 YR
• Patient Sex: Female