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

Model Number D134801

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

Patient Problem Laceration(s) of Esophagus (2398)

Event Date 08/25/2020

Event Type  Injury  

Manufacturer Narrative

Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device lot# 30380204m, and no internal actions related to the complaint was found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(6).(b)(4).Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent cardiac ablation procedure with thermocool® smart touch® sf bi-directional navigation catheter and suffered esophageal ulcer.No intervention was reported.After the procedure was completed, erosion of the esophagus was confirmed with an endoscope.The patient has been followed-up.The physician¿s commented that they are using an esophageal [temperature] sensor and the posterior wall in the isolation of left pulmonary vein (lpv) is done at 30 w and when the sensor becomes ablation [temperature rises] they stop ablation.The sensor is set to 40 degrees celsius, but in the future, it will be changed to 39 degree celsius.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.Since the event was discovered immediately after the procedure and there was no report of intervention this will not be considered as ¿atrioesophageal fistula¿.Since the model of the generator is not available at this time the ip for the generator is voided.Should more information become available in the future; the reportability decision will be reassessed.

Manufacturer Narrative

E4.Reporter also sent report to fda? - no.Product complaint # (b)(4).

Manufacturer Narrative

During an internal review on september 29, 2020, a correction to "d11.Concomitant medical products and therapy dates" section was observed as the model of the generator was not available at this time.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

During an internal review on (b)(6)2020, a correction was noted to the 3500a follow-up report #1 under ¿g4.Date received by manufacturer¿ as it was submitted as (b)(6)2020; however, it should have been (b)(6)2020.In addition, ¿d8.Is this a single-use device?¿ should have been blank but was processed as ¿no¿ as this information was already submitted under the 3500a initial report.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

Additional information was received on the event on (b)(6) 2020 stating that the patient had recovered and extended hospitalization was required.Therefore, processed b2.Is hospitalization initial/prolonged field.In addition added in h6.Health effect - impact code "hospitalization or prolonged hospitalization (f08)." if additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (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: 10577391
• MDR Text Key: 208783982
• Report Number: 2029046-2020-01316
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010145
• UDI-Public: 10846835010145
• 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,Followup,Followup,Followup
• Report Date: 09/02/2020

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 Expiration Date: 06/16/2021
• Device Model Number: D134801
• Device Catalogue Number: D134801
• Device Lot Number: 30380204M
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/02/2020
• Initial Date FDA Received: 09/23/2020
• Supplement Dates Manufacturer Received: 09/02/2020; 09/29/2020; 09/29/2020; 12/09/2020
• Supplement Dates FDA Received: 09/23/2020; 09/29/2020; 09/29/2020; 01/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN BRAND GENERATOR
• Patient Outcome(s): Hospitalization; Other