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 Paresis (1998)

Event Date 02/04/2022

Event Type  Injury  

Manufacturer Narrative

Initial reporter phone: (b)(6).Information received indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Investigation is in progress, once completed a supplemental will be submitted.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 male patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered gastric dilatation requiring prolonged hospitalization.The patient's procedure was on (b)(6) 2022 and it has been found that post procedure gastric dilatation occurred.The procedure was analyzed by the physician, the agent, and the j&j staff on (b)(6) 2022.The esophagus was close to the right pulmonary vein (rpv).There was a place that when the ablation was delivered up to ai value 400 and it was near the esophagus.Therefore, it is inferred that this area may have caused gastric dilatation.The patient seemed to be doing well and has started eating.The physician¿s opinion on the cause of this adverse event was that it was procedure related.The physician commented that nerves may have been injured when the right pulmonary vein was ablated.No additional intervention conducted.The patient outcome of the adverse event was improved and the x-ray results showed that the gastric dilatation had subsided.However, since the patient had vomiting symptoms, the patient was scheduled to visit the hospital as an outpatient later.The patient required extended hospitalization because of the adverse event for follow up.Biosense webster devices were used as per the instructions for use (ifu).Additional information received on 25-feb-2022.The patient looks fine and will start eating.On the judgment of the physician in charge, non-serious and there is a possibility that the nerve was injured when the right pulmonary vein was energized.

Manufacturer Narrative

The investigation was completed on 03-mar-2022.Information received indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30661482l 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).

• Brand Name: THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez ; MX
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13654623
• MDR Text Key: 288599327
• Report Number: 2029046-2022-00432
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/18/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30661482L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/19/2021
• 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
• Treatment: 7FR DECAN,11P,F,2.4MMLE,282MM,; PENTARAY NAV ECO 7FR, D, 2-6-2.; SOUNDSTAR ECO SMS 8F CATHETER.; UNK_SMARTABLATE GENERATOR.
• Patient Outcome(s): Hospitalization
• Patient Sex: Male