MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNKNOWN CARTO VIZIGO SHEATH; INTRODUCER, CATHETER

Catalog Number UNK_CARTO VIZIGO SHEATH

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Air Embolism (1697); Ventricular Fibrillation (2130)

Event Date 08/13/2021

Event Type  Injury  

Manufacturer Narrative

Initial reporter phone: (b)(6).Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturer record evaluation cannot be conducted because the no lot number was provided by the customer.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 Description

It was reported that a (b)(6) male patient ((b)(6)) underwent an atrial fibrillation (afib) with an unknown carto vizigo sheath.The case was a cryo and carto 3 case.The patient suffered possible air embolism, st segment elevations leading to ventricular fibrillation.In the procedure of cryo in combination with carto3, air embolism may have occurred, though it is not certain.St increased during the procedure and shifted to vf, and then stopped with dc.The procedure was continued, and the procedure was completed without any problem.The physician commented that not related to our company product.The physician¿s opinion on the cause of this adverse event: there¿re no relationship with bwi products.Intervention provided: direct cardioversion was conducted.Patient outcome of the adverse event: fully recovered.It is life threatening; it might result in permanent impairment of a body function or permanent damage to a body structure; or it required medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure.

• Brand Name: UNKNOWN CARTO VIZIGO SHEATH
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (IRVINE); 33 technology drive; irvine CA 92618
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12445180
• MDR Text Key: 270532186
• Report Number: 2029046-2021-01506
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_CARTO VIZIGO SHEATH
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/12/2021
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ACUNAV; CARTO 3 SYSTEM; LASSO NAV; SMARTABLATE PUMP
• Patient Outcome(s): Life Threatening; Required Intervention