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

Model Number D135303

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Hemorrhage/Bleeding (1888); Ventricular Fibrillation (2130); Heart Block (4444)

Event Date 02/17/2022

Event Type  Injury  

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 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.

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
• Type of Device: 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
• MDR Text Key: 290467680
• Report Number: 2029046-2022-00570
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835009972
• UDI-Public: 10846835009972
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K080425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 04/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2021
• 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: SOUNDSTAR ECO SMS 8F CATHETER; UNK IMPELLA HEART PUMP
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening
• Patient Age: 46 YR
• Patient Sex: Male