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

Catalog Number D134805

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Fistula (1862); No Consequences Or Impact To Patient (2199)

Event Date 02/26/2019

Event Type  Injury  

Manufacturer Narrative

No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.As such the investigation will be closed.If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.Manufacturing record evaluation cannot be conducted because no lot number was provided by the customer.Concomitant bwi products: carto® 3 system (us catalog # fg540000, serial # (b)(4)); pentaray d curve catheter (us catalog # unknown, lot # unknown); webster cs unidirectional f curve catheter (us catalog # unknown, lot # unknown).Manufacturer¿s ref # (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a smartablate generator and suffered esophageal fistula.During the procedure, the patient suffered esophageal fistula.It is unknown if medical/surgical intervention was required.There¿s no information regarding extended hospitalization, patient¿s outcome or physician causality opinion.Multiple attempts have been made to gain clarification on this event with no response.Should any new information be obtained it will be assessed and processed accordingly.Biosense webster manufacturer's reference number (b)(4) has two reports related to the same event: mfr # 2029046-2019-02852 for product code unk_smartablate generator (smartablate generator); mfr # 2029046-2019-02855 product code d134805 (thermocool® smart touch® sf bi-directional navigation catheter).

Manufacturer Narrative

On 3/21/2019, confirmation was received from the biosense webster inc.Clinical account specialist, that it was discovered the patient did not have an atrial esophageal fistula.No patient consequences occurred from this procedure.However, since this event has already been reported to fda, biosense webster inc.Will continue to report supplemental mdrs to fda as additional information is received regarding this event.Patient code updated from 1862 (fistula) to 2199 (no consequences or impact to patient).Device code updated from 2993 (adverse event without identified device or use problem) to 3189 (no apparent adverse event).Manufacturer¿s ref # (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 8438789
• MDR Text Key: 139422869
• Report Number: 2029046-2019-02855
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• 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
• Type of Report: Initial,Followup
• Report Date: 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D134805
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening