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 Problems Hemorrhage/Bleeding (1888); Paresis (1998)

Event Date 01/01/2022

Event Type  Injury  

Event Description

It was reported that a (b)(6) female patient underwent an ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered gastric dilatation, bleeding and prolonged hospitalization.After the procedure there was no problem.One week after the procedure gastric dilatation and bleeding from the stomach occurred and if the bleeding did not stop, hemostasis is scheduled to be performed with a gastroscope.The patient is currently hospitalized.The physician commented that in carto3 review data, the visitags near the esophagus, but there was no place where the contact was extremely high.The ai's value on the esophagus was 350 at the highest point, the value was about 400 near the esophageal line, and there were some places where the value was 450.Ablation on or around the esophagus was not so excessive.The physician¿s opinion on the cause of this adverse event was the procedure.The physician commented that the event was due to esophageal vagal nerve disorder caused by electrical current.The patient required extended hospitalization because of the adverse event.The patient was readmitted on (b)(6) 2022.According to the gastroenterologist, the patient may have had gastric ulcer from the beginning.The stomach was already weak, so it might have been easy to bleed.Ablation may have caused further stress due to gastric dilatation, leading to bleeding.Hemostasis of the bleeding site was performed and the patient was kept under observation with abstinence from eating and drinking.Additional information was received on 25-mar-2022: progress update; patient currently in hospital and if there is bleeding from the stomach and the bleeding does not stop, hemostasis will be performed with a gastrocamera.Revision of statement above regarding gastroenterologist to; according to the doctor, there may have been a stomach ulcer originally.The stomach was originally weak, so it may have been easy to bleed.The ablation may have caused gastric distension, further stress, and bleeding.

Manufacturer Narrative

Initial reporter phone: (b)(6).The device has been reported as discarded, 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).

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4) during an internal review on 30-mar-2022, noted a correction to the 3500a initial as the physician information was not included.Therefore, updated the e.Initial reporter section.

Manufacturer Narrative

Additional information was received on 10-apr-2022.The patient¿s weight is 52kg.Intervention provided was hemostasis will be performed with gastroscopy.The patient outcome of the adverse event was improved.Hemostasis of the bleeding site was performed, and the patient was kept under observation with abstinence from eating and drinking.The patient required extended hospitalization due to extended observation with no eating and drinking.Therefore, updated a 4.Weight of the patient and a 4.Weight unit.In addition, the physician information was provided.Therefore, section e.Initial reporter was processed.The investigation was completed on 28-apr-2022.The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device number 30669576l 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.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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 6465917981
• MDR Report Key: 13960512
• MDR Text Key: 288282958
• Report Number: 2029046-2022-00679
• 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,Followup
• Report Date: 05/02/2022

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: 10/27/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30669576L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/30/2022
• Initial Date FDA Received: 03/31/2022
• Supplement Dates Manufacturer Received: 03/30/2022; 04/10/2022
• Supplement Dates FDA Received: 03/31/2022; 05/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2021
• 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: 8.5F SHEATH WITH CURVE VIZ SMC; PENTARAY NAV ECO 7FR, D, 2-6-2; SOUNDSTAR ECO SMS 8F CATHETER; UNK_CARTO 3; UNK_SMARTABLATE GENERATOR
• Patient Outcome(s): Hospitalization
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 52 KG