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

Model Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Laceration(s) of Esophagus (2398)

Event Date 12/22/2020

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.However, a picture showing carto 3 display and ablation setting was received for analysis.The photo does not provide sufficient information related to the reported event and therefore no result can be obtained from it.A manufacturing record evaluation was performed for the finished device 30462282l number, and no internal action 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.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent cardiac ablation procedure for persistent atrial fibrillation with thermocool® smart touch® sf bi-directional navigation catheter and suffered esophageal injury requiring hospitalization.Dashboard, vector and visitag were used for force visualization.The visitag parameters were 4mm, 3sec with ablation index as additional filter.There was no perforation but a thermal lesion happened.Lesion was detected after the procedure (on the next day).There were no error messages observed on biosense webster equipment during procedure.Short time ablation was used as modality to prevent esophageal injury.The carto system did not indicate to re-zero the catheter.Since this event required prolonged hospitalization it is mdr reportable.

• 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
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 11160460
• MDR Text Key: 226789772
• Report Number: 2029046-2021-00048
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/05/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30462282L
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization