MAUDE Adverse Event Report: BIOSENSE WEBSTER INC EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number	BNI75TCDFH
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	04/08/2022
Type of Reportable Event	Serious Injury
Additional 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.A manufacturing record evaluation was performed for the finished device number 30670389m 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 or Problem Description
It was reported that a male patient underwent a ventricular tachycardia (vt) ablation procedure with an ez steer¿ thermocool® nav bi-directional catheter.The patient suffered right coronary artery aneurysm requiring surgical intervention.During epicardial ablation, when coronary angiography (cag) was conducted, an aneurysm was confirmed at the periphery of the right coronary artery.Although it was unknown whether the issue was caused by ablation, percutaneous coronary intervention (pci) was performed.This occurred after ablation, when pericardial drainage was performed.The issue was resolved by conducting the pci.The procedure was ended without problem and the patient returned to the ward.Coronary artery injury; since the catheter had no contact force (cf), there was no cf monitoring; it was confirmed by fluoroscopy by the physician.The procedure was completed without any problem after pci.The physician will describe their opinion on the relationship between the event and the product after checking.Medical history/treatment history/other diseases currently being treated includes brugada electrocardiogram.Additional information was received on the event.This adverse event was discovered during use of biosense webster products.Pci was the intervention provided.The patient outcome of the adverse event is fully recovered with no residual effects.No pericardial effusion or cardiac tamponade was reported.No steam pop was reported.Cardiac tamponade and pericardial effusion are not coded as in additional information it was reported that no pericardial effusion or cardiac tamponade was reported.
Additional Manufacturer Narrative
Additional information was received on the event on (b)(6) 2022.The patient was a 68-year-old patient (55kg).The physician¿s opinion on the cause of this adverse event was not related with the bwi product malfunction.The patient outcome of the adverse event was improved.The patient did not require extended hospitalization because of the adverse event.The patient had brugada electrocardiogram waveform, an icd implanted and the was icd activated with vf storm.A transseptal puncture was not performed.The event occurred when the reporter tried to measure act after energization, arterial blood was found.Cag revealed the event.The irrigated catheter flow setting was pre time:2 sec, post time:5sec.The correct catheter settings were selected on the generator and the pump switching from low to high flow during ablation.No error messages were observed on biosense webster equipment during the procedure.Therefore, updated d 10.Concomitant medical products and therapy dates field and a.Patient information section.In addition, the physician information was provided.Therefore, updated e.Initial reporter section.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: EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• 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 ; 646591-7981
• MDR Report Key: 14284199
• Report Number: 2029046-2022-00949
• Device Sequence Number: 5284446
• Product Code: OAD
• UDI-Device Identifier: 10846835003338
• UDI-Public: 10846835003338
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P030031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/16/2024
• Device Model Number: BNI75TCDFH
• Device Catalogue Number: BNI75TCDFH
• Device Lot Number: 30670389M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2022
• Supplement Date Received by Manufacturer: 04/08/2022
• Initial Report FDA Received Date: 05/04/2022
• Supplement Report FDA Received Date: 06/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PENTARAY NAV ECO 7FR, D, 2-6-2; UNKNOWN BRAND PUMP; UNK_SMARTABLATE GENERATOR
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 55 KG