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

Model Number D138503

Device Problem Backflow (1064)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2022

Event Type  malfunction  

Event Description

Bubbles in the hemostaseventil.After changing to another sheet we can finished the procedure successful.Was surgery delayed due to the reported event? unknown.Was procedure successfully completed? unknown.Were fragments generated? unknown.If yes, were they removed easily without additional intervention? unknown.Patient status/ outcome / consequences? no.Was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown.Is the patient part of a clinical study? unknown.(b)(4).Device property of: none.Device in possession of: none.By checking this box i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted through cst: true.

Manufacturer Narrative

Date of event - the exact date is unknown and therefore, (b)(6) 2022 was entered on this field.Product complaint # (b)(4).

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4) during an internal review on 26-jul-2022, it was noted that the b5.Event description of the 3500a initial report needed to be updated.Therefore, this field was updated on this report.In addition, the following statements were inadvertently omitted from the h10.Additional manufacturer narrative : ¿this report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.¿.

Event Description

It was reported that a patient underwent a cardiac ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ large and air flows back into the side port issue occurred.It was reported that there were bubbles in the hemostatic valve area.Air was not being introduced into the patient.The physician performed maneuvers to eliminate bubbles.He aspirated several times.No medical intervention was required.The patient has not exhibited any neurological symptoms since the procedure was completed.After changing to another sheath, the procedure was successfully completed.There were no patient consequences.

Manufacturer Narrative

The biosense webster inc.(bwi) product analysis lab received the device for evaluation on 16-aug-2022.The device evaluation was completed on 25-aug-2022.It was reported that a patient underwent a cardiac ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ large and air flows back into the side port issue occurred.It was reported that there were bubbles in the hemostatic valve area.Air was not being introduced into the patient.The physician performed maneuvers to eliminate bubbles.He aspirated several times.No medical intervention was required.The patient has not exhibited any neurological symptoms since the procedure was completed.After changing to another sheath, the procedure was successfully completed.There were no patient consequences.Device evaluation details: the product was returned to biosense webster (bwi) for evaluation.Bwi then conducted a visual inspection and a functional test of the side port.Visual analysis of the returned sample revealed that no damage was observed on the vizigo sheath.The returned sample was connected to a syringe with water and no leakage was observed.Then the functional test of the side port was performed, and no issues were observed.A device history record (dhr) review was performed for the finished device number 00001742, and no internal actions related to the complaint were found during the review.Based on the dhr, the h4.Device manufacture date has been updated.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.Therefore, no capa activity is required.The instructions for use contain the following warning stated in the ifu: before inserting the sheath into the patient, flush the sheath and dilator with heparinized normal saline to remove air bubbles and any potential particulate.After the sheath is in the left atrium of the patient, maintain a constant flow of heparinized normal saline to the sheath to minimize the risk of air emboli.The event described could not be confirmed as the device was returned without detectable damage.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.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 ¿ LARGE
• 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 ; 646591-798
• MDR Report Key: 15108975
• MDR Text Key: 298790930
• Report Number: 2029046-2022-01712
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835016260
• UDI-Public: 10846835016260
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K170997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/03/2022
• Device Model Number: D138503
• Device Catalogue Number: D138503
• Device Lot Number: 00001742
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2021
• 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: UNK BRAND SHEATH.