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

Model Number D134805

Device Problems Failure to Sense (1559); Patient Device Interaction Problem (4001)

Patient Problem Ischemic Heart Disease (2493)

Event Date 11/08/2022

Event Type  Injury  

Event Description

It was reported that a male patient underwent a atrial fibrillation (afib) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ small and thermocool® smart touch® sf bi-directional navigation catheter.The hemostatic valve was found to be damaged during insertion of the ablation catheter.There was reverse blood.After that, the wire was inserted for replace the sheath, and the sheath was pulled out.Then, the patient's st value increased, blood pressure and hr decreased.Timing when complaints occurred was after placing vizgo in the left atrium, at the time of insertion of ablation catheter.Vizgo sheath replacement.Patient¿s consciousness was confirmed, and hr was increased by pacing and maintained.Thereafter, both st and electrocardiogram (ecg) returned to normal value over time, and the procedure was continued.No abnormality in the patient after the end of the procedure.The physician's opinions on the relationship between the event and the product was that air may have entered when the wire was inserted, and the sheath was pulled out.There were no abnormalities observed prior to and during use of the product.Sheath was used on the patient.The possibility of air entering the patient¿s body was pointed out by the physician, but it was not confirmed.The patient condition was recovered with pacing.The adverse event was discovered during use of biosense webster products.The physician¿s opinion on the cause of this adverse event was the patient condition ---air may have entered when the wire was inserted, and the sheath was pulled out.Patient's consciousness was confirmed, and hr was increased by pacing and maintained.Thereafter, both st and ecg returned to normal value over time, and the procedure was continued.The outcome of the adverse event was fully recovered.Physician did not perform any maneuver to eliminate bubbles.Patient did not exhibit any neurological symptoms since the procedure was completed.Since the event is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr-reportable.Biosense webster manufacturer's reference number (b)(4) has 2 reports.The vizigo sheath was reported as a malfunction report for the hemostatic valve separation and air flow into side port.

Manufacturer Narrative

Initial reporter phone number: (b)(6).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 number lot 30886354l and no internal action related to the complaint was found during the review.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc.Or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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

On 30-nov-2022, bwi received additional information regarding the event.Patient¿s age- 61 years, weight- 74kg.Clinical course-at a later check, there were no postoperative abnormalities, neurological symptoms, or extension of hospitalization.The patient has been already discharged from the hospital.The physician's opinions on the relationship between the event and the product was that although the amount of bleeding was not clearly known, about 30 cc.The hub was not visible on the outside and may have dropped out on the inside.There is no photo because the product has already been sent.[relevant medical history]: anemia.On 14-dec-2022, the bwi product analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report 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) per internal review, it was identified that details were mistakenly omitted from the initial report.Situation-106 sensor error occurred when some points got with using the ablation catheter before ablation.Timing when complaints occurred- when some points of left atrial got with using the ablation catheter before ablation.The issue was resolved by replacing the smart touch sf catheter.

Manufacturer Narrative

On 23-dec-2022, bwi received additional information regarding the event.The hemostasis valve (gasket) dislodged inside the hub but not outside the hub.The brim cap/hub did not detach from the sheath.No picture available.The sheath was used on the patient.The possibility of air entering the patient¿s body was pointed out by the physician, but it was not confirmed.The patient condition was recovered with pacing.The approximate volume of blood that was lost was about 30cc.The adverse event was discovered during use of biosense webster products.Physician¿s opinion on the cause of this adverse event was that air may have entered when the wire was inserted, and the sheath was pulled out.Patient's consciousness was confirmed, and hr was increased by pacing and maintained.Thereafter, both st and ecg returned to normal value over time, and the procedure was continued.Outcome of the adverse event was fully recovered.Patient did not require extended hospitalization because of the adverse event.Relevant tests/laboratory data was none.Smartablate generator was used.Physician did not perform any maneuver to eliminate bubbles.Patient did not exhibit any neurological symptoms since the procedure was completed.Additionally, the product investigation was completed on 27-dec-2022.Device evaluation details: visual analysis revealed that no damage or anomalies on the device.Per the event, several tests were performed.The magnetic, electrical, temperature and force features were tested and error 106 was observed due to an open circuit in the tip area.In addition, the product was deflecting and irrigating correctly.A manufacturing record evaluation was performed for the finished device number lot 30886354l and no internal action related to the complaint was found during the review the force issue reported by the customer was confirmed, the root cause of the adverse event remains unknown.The instruction for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.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 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 15867688
• MDR Text Key: 304331405
• Report Number: 2029046-2022-02978
• 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,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/10/2023

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 Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30886354L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/07/2022
• Initial Date FDA Received: 11/28/2022
• Supplement Dates Manufacturer Received: 11/30/2022; 12/23/2022
• Supplement Dates FDA Received: 12/20/2022; 01/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2022
• 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: SMARTABLATE GENERATOR
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 74 KG