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

Model Number D133602

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pulmonary Edema (2020); Blood Loss (2597)

Event Date 10/06/2020

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 30326569m number, and no internal action related to the reported complaint was found during the review.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 ref.# (b)(4).

Event Description

During a clinical trial, sponsored by bwi, it was reported that a (b)(6) year-old female patient (82.4 kg, 66 in) underwent a cardiac ablation procedure on (b)(6) 2020 with a thermocool® smart touch¿ electrophysiology catheter and post procedure developed pulmonary edema and bleeding.A total of 110 radiofrequency applications were delivered with the thermocool® smart touch¿ electrophysiology catheter.No device deficiencies were reported.The procedure was successfully completed without patient consequences.Post-procedure, on (b)(6) 2020, the patient developed leakage of blood into lungs (pulmonary edema) and left atrial septal mass hematoma (less likely thrombus).No medical/surgical intervention nor extended hospitalization was required (patient was discharged the same day).Issue is resolving.The principal investigator assessed the event as expected, mild in severity, not serious, not related to the study device (visitag surpoint epu), probable related to the study catheter, not related to the bwi non-investigational devices (e.G.Pump, tubing, cables, etc) and probable related to the index procedure.Due to the implied relationship to the study catheter and procedure, this event is being coded as ¿pulmonary edema¿ and ¿bleeding¿.Bleeding code is being selected to represent the left atrial septal mass hematoma reported for this clinical study.Source documentation will be requested to obtain further details/clarification regarding this event.Should more information become available, it will be reviewed and processed accordingly.

Manufacturer Narrative

On 11/18/2020, biosense webster inc.Received additional information indicating the adverse event term has been updated from ¿leakage of blood into lungs or other organs due to perforation¿ to ¿left atrial septal mass hematoma vs.Less likely thrombus¿ on 11/25/2020, additional information was received indicating there was no leakage of blood into the lungs, as such, this event will no longer be considered to be a pulmonary edema and no longer considered to be an mdr reportable event.The reported left atrial septal mass hematoma is considered to be a non-serious patient event since there were no interventions and no extended hospitalization was required to treat the septal mass hematoma.Source documentation indicates ¿there were no intraprocedural complications¿.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# pc-(b)(4).

• Brand Name: THERMOCOOL SMART TOUCH ELECTROPHYSIOLOGY CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 10797357
• MDR Text Key: 215074466
• Report Number: 2029046-2020-01641
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009002
• UDI-Public: 10846835009002
• Combination Product (y/n): N
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,study
• Type of Report: Initial,Followup
• Report Date: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/09/2021
• Device Model Number: D133602
• Device Catalogue Number: D133602
• Device Lot Number: 30326569M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; CARTO3 EXTERNAL REFPATCH 6PACK; CBL, 34 HYP/34 LEMO, 10'; SMARTABLATE GENERATOR KIT-US; SMARTABLATE PUMP KIT-US; VISITAG SURPOINT EPU; CARTO 3 SYSTEM; CARTO3 EXTERNAL REFPATCH 6PACK; CBL, 34 HYP/34 LEMO, 10'; SMARTABLATE GENERATOR KIT-US; SMARTABLATE PUMP KIT-US; VISITAG SURPOINT EPU
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Weight: 82