MAUDE Adverse Event Report: BIOSENSE WEBSTER INC DECANAV ELECTROPHYSIOLOGY CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number R7D282CT

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Cardiac Arrest (1762); Myocardial Infarction (1969)

Event Date 10/27/2021

Event Type  Injury  

Event Description

It was reported that an unknown patient underwent a supraventricular tachycardia (svt) ablation procedure with a decanav electrophysiology catheter.The patient suffered cardiac arrest which required surgical intervention.It was reported that the patient coded on the cart in the stretcher after the procedure.It was noticed as the patient's blood pressure dropped.Which was confirmed by no pulse, no breathing, and no hear rate.The patient received cpr, a heart cath in the cath lab, a coronary angiogram and stent placement.The patient is in the icu for observation.Since the event is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure and it required 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.

Manufacturer Narrative

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 30559740m 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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(4).

Manufacturer Narrative

On 12-nov-2021, bwi received additional information regarding the event.The patient is male.This adverse event was discovered post use of biosense webster products.The physician¿s opinion on the cause of this adverse event: myocardial infarction (mi) intervention was provided: cardiac cath.Patient outcome of the adverse event: fully recovered (no residual effects).The patient required extended hospitalization because of the adverse event: due to post mi care.Past medical history: known cad.Cpr was performed.Section h6 health effect - impact code "hospitalization or prolonged hospitalization" added.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: DECANAV ELECTROPHYSIOLOGY CATHETER
• 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: 12832152
• MDR Text Key: 283490136
• Report Number: 2029046-2021-01996
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835008791
• UDI-Public: 10846835008791
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/28/2021

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: 05/03/2022
• Device Model Number: R7D282CT
• Device Catalogue Number: R7D282CT
• Device Lot Number: 30559740M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/27/2021
• Initial Date FDA Received: 11/17/2021
• Supplement Dates Manufacturer Received: 11/12/2021
• Supplement Dates FDA Received: 11/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2021
• 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
• Patient Outcome(s): Required Intervention; Hospitalization; Life Threatening
• Patient Sex: Male