MAUDE Adverse Event Report: BIOSENSE WEBSTER INC WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	D135303
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Ventricular Fibrillation (2130); Heart Block (4444)
Date of Event	02/17/2022
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 30691787m number, and no internal action related to the complaint was found during the review.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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 a webster cs catheter with auto id technology and suffered ventricular fibrillation requiring surgical intervention.It was reported that at a vt procedure, vt persisted (hemodynamics did not stabilize), so burst pacing was performed through a catheter placed in the heart, but the vt did not stop.The vt shifted to ventricular fibrillation (vf), and it was stopped by external cardioversion, but blood pressure did not increase.Finally, an impella device, a pump catheter for auxiliary circulation was placed intracardially to stabilize hemodynamics.The procedure was then completed.According to the physician's comment, the patient had a background that ¿the original cardiac function was not good.¿ ablation was not done, so there was no causal relationship with the product.The procedure caused massive bleeding and the product could not be collected.The complaint product will not be returned for analysis.The soundstar eco catheter lot number is e8350469.This adverse event was discovered during use of biosense webster products.The physician¿s opinion on the cause of this adverse event is that it was patient condition related.The patient outcome of the adverse event was reported as improved.Follow up has been requested to clarify why ¿heart block¿ was written in the initial report, as no further details about heart block was provided.Until clarification is received, heart block will not be coded as event description provided described ventricular fibrillation and not heart block.Once clarification is received, this information will be reassessed accordingly.
Additional Manufacturer Narrative
Additional information was received.It was reported that the patient is 46 years old.Therefore, a 2.Patient age at the time of event and a 2.Age unit have been updated.The physician¿s name has been provided.Therefore, e 1.Initial reporter title, e 1.Initial reporter first name, e1.Initial reporter last name and h 2.Health professional? have been updated.The patient required extended hospitalization because of the adverse event but details are unknown.Therefore, b 2.Is hospitalization initial/prolonged and h 6.Health effect - impact code have been updated.Clarification has been received from the bwi representative.Heart block was being reported in addition to ventricular fibrillation (vfib).Blood pressure did not rise after vfib was stopped, and the physician judged it as heart block.An impella was implanted against the heart block.The h6.Health effect - clinical code has been updated to include heart block (e060106).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: WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13817616
• Report Number: 2029046-2022-00570
• Device Sequence Number: 19383455
• Product Code: DRF
• UDI-Device Identifier: 10846835009972
• UDI-Public: 10846835009972
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K080425
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2022

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: 11/30/2024
• Device Model Number: D135303
• Device Catalogue Number: D135303
• Device Lot Number: 30691787M
• 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: 02/17/2022
• Supplement Date Received by Manufacturer: 04/12/2022
• Initial Report FDA Received Date: 03/19/2022
• Supplement Report FDA Received Date: 05/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2021
• 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: SOUNDSTAR ECO SMS 8F CATHETER; UNK IMPELLA HEART PUMP
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Life Threatening
• Patient Age: 46 YR
• Patient Sex: Male