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

Catalog Number D134804

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 product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.On 5/24/2019, a manufacturing record evaluation was performed, and no internal actions were found during the review.Biosense webster manufacturer's reference number (b)(4) has two complaints that are related to the same incident.Reports 2029046-2019-03197 and 2029046-2019-03199 are related to this same incident.Manufacture reference no: (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 thermocool® smart touch® sf bi-directional navigation catheter and a smartablate¿ system rf generator 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.Patient date of birth of (b)(6) 1945 was added to section a2, section b2 life threatening has been checked off, ca state abbreviation was added to section g1, and not returned to manufacturer was added to section h3 of this report.Manufacture reference no: (b)(4).

• Brand Name: THMCL SMTCH SF BID, TC, F-J
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 8663684
• MDR Text Key: 146833153
• Report Number: 2029046-2019-03197
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: 10846835010176
• Combination Product (y/n): N
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/27/2019
• Device Catalogue Number: D134804
• Device Lot Number: 30145617L
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PENTARAY NAV ECO 7FR, D, 2-6-2; SMARTABLATE GENERATOR KIT-WW; ST. JUDE SENSITHERM ESOPHAGEAL PROBE; PENTARAY NAV ECO 7FR, D, 2-6-2; SMARTABLATE GENERATOR KIT-WW; ST. JUDE SENSITHERM ESOPHAGEAL PROBE
• Patient Outcome(s): Death; Life Threatening
• Patient Age: 74 YR