MAUDE Adverse Event Report: BIOSENSE WEBSTER INC CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM; INTRODUCER, CATHETER

Model Number D138502

Device Problems Backflow (1064); Patient Device Interaction Problem (4001)

Patient Problem Air Embolism (1697)

Event Date 03/10/2022

Event Type  Injury  

Manufacturer Narrative

Initial reporter phone: (b)(6).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 an unknown patient underwent an unknown ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium.The patient suffered an air embolism and air in the sheath.When the doctor pulls-out the dilator from the sheath, he noticed the presence of one big bubble in the transparent hemostasis valve at the initial part of the handle.The only way to remove it is to flush the sheath in the right atrium.The same bubble shows once the catheter has been pulled off from left atria in to the vizigo to insert the pentaray.The patient had not exhibited any neurological symptoms since the procedure was completed.The procedure was delayed 5 minutes and was successfully completed with no patient consequences.No additional medical intervention was required.The event was discovered while using the vizigo bwi product.The physician¿s opinion on the cause of this adverse event was a bwi product malfunction.The patient was reported to have fully recovered (no residual effects).No extended hospitalization was required.Air flow back into side port is mdr-reportable.Since the event is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require 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

On 10-may-2022, the product investigation was completed as the complaint device was not returned.The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A device history records was performed for the finished device 50000029 number, and no internal actions related to the complaint were 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).

• Brand Name: CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM
• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 6465917981
• MDR Report Key: 13983583
• MDR Text Key: 289507765
• Report Number: 2029046-2022-00703
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835016277
• UDI-Public: 10846835016277
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K170997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/29/2022
• Device Model Number: D138502
• Device Catalogue Number: D138502
• Device Lot Number: 50000029
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2021
• 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: PENTARAY NAV CATHETER.; UNSPECIFIED PUMP.
• Patient Outcome(s): Required Intervention; Life Threatening