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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOSENSE WEBSTER INC SMARTABLATE¿ SYSTEM RF GENERATOR; CARDIAC ABLATION PERCUTANEOUS CATHETER
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BIOSENSE WEBSTER INC SMARTABLATE¿ SYSTEM RF GENERATOR; CARDIAC ABLATION PERCUTANEOUS CATHETER Back to Search Results
Catalog Number M4900107
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Fistula (1862)
Event Date 05/01/2019
Event Type  Death  
Manufacturer Narrative
The hardware investigation has begun but it has not been completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.Biosense webster manufacturer's reference number (b)(4) has two complaints that are related to the same incident.Reports 2029046-2019-03199 and 2029046-2019-03197 and are related to this same incident.(b)(4).
 
Event Description
It was reported that a female patient underwent a left sided atrial flutter ablation procedure on (b)(6) 2019 with a smartablate¿ system rf generator and a thermocool® smart touch® sf bi-directional navigation catheter and suffered esophageal fistula and death.About 1 month after the procedure, the patient developed esophageal fistula.Surgical intervention was not performed.It is unknown if extended hospitalization was required.The patient was transferred to another facility and died following a coma.The brain scanner showed febrile pneumocephaly.It is impossible to determine the location of the fistula.The patient expired approximately on (b)(6) 2019.Physician¿s opinion regarding the cause of the adverse event is that it was procedure and patient condition related.The generator was used in power control mode at 30 watts posterior and between 35-40 watts anterior.A sensitherm st.Jude medical esophageal probe was used as modality to prevent esophageal injury.
 
Manufacturer Narrative
It was reported that a female patient underwent a left sided atrial flutter ablation procedure on (b)(6) 2019 with a thermocool® smart touch® sf bi-directional navigation catheter and a smartablate¿ system rf generator and suffered esophageal fistula and death.During an internal review it was noticed that sections age or date of birth and outcomes attributed to adverse event, were omitted in error.Patient date of birth of (b)(6) 1945 was added and life threatening has been checked off in this report.Sections common device name,pro code, catalog and udi were erroneously reported.Common device name cardiac ablation percutaneous catheter was added, pro code: lpb was added, and catalog # m4900107 and udi (b)(4) were added.Manufacture ref no: (b)(4).
 
Manufacturer Narrative
It was reported that a female patient underwent a left sided atrial flutter ablation procedure on (b)(6) 2019 with a smartablate¿ system rf generator and a thermocool® smart touch® sf bi-directional navigation catheter and suffered esophageal fistula and death.The investigational analysis completed (b)(6) 2019.Repair follow-up was performed and device was not shipped for service.Device cannot be evaluated.Dhr was reviewed.It was verified that the device was manufactured in accordance with documented specification and procedures.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacture reference no: (b)(4).
 
Manufacturer Narrative
It was reported that a female patient underwent a left sided atrial flutter ablation procedure on (b)(6) 2019 with a smartablate¿ system rf generator and a thermocool® smart touch® sf bi-directional navigation catheter and suffered esophageal fistula and death.Additional information was received (b)(6) 2019, indicating the manufacture date of (b)(6) 2013 for the smartablate¿ system rf generator.Device manufacturer date of this report has been updated.Manufacture ref no: (b)(4).
 
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Brand Name
SMARTABLATE¿ SYSTEM RF GENERATOR
Type of Device
CARDIAC ABLATION PERCUTANEOUS CATHETER
Manufacturer (Section D)
BIOSENSE WEBSTER INC
33 technology drive
irvine CA 92618
MDR Report Key8663705
MDR Text Key146837173
Report Number2029046-2019-03199
Device Sequence Number1
Product Code LPB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup,Followup
Report Date 05/07/2019
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 Catalogue NumberM4900107
Initial Date Manufacturer Received 05/07/2019
Initial Date FDA Received06/03/2019
Supplement Dates Manufacturer Received06/04/2019
06/11/2019
12/03/2019
Supplement Dates FDA Received06/05/2019
07/02/2019
12/26/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
PENTARAY NAV ECO 7FR, D, 2-6-2.; ST. JUDE SENSITHERM OESOPHAGEAL PROBE.; THMCL SMTCH SF BID, TC, F-J.; PENTARAY NAV ECO 7FR, D, 2-6-2; ST. JUDE SENSITHERM OESOPHAGEAL PROBE; THMCL SMTCH SF BID, TC, F-J
Patient Outcome(s) Death; Life Threatening;
Patient Age74 YR
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