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

Model Number D138501

Device Problem Material Separation (1562)

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

Event Date 01/01/2022

Event Type  malfunction  

Manufacturer Narrative

On 23-aug-2022, the bwi product analysis lab received the complaint device for evaluation.The product analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.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.Note: the date of event was not provided.Date of event has been populated with (b)(6) 2022.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.(b)(4).

Event Description

It was reported that a patient underwent a cardiac ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ small and a hemostatic valve separation occurred.It was reported there was a hemostatic valve defect.There were no patient consequences.Blood came out of the valve.Back bleeding was noticed due to valve probably being dislodged.The hemostatic valve (gasket) did not break into two or more separate pieces, and it did not become detached from the sheath.The carto vizigo¿ 8.5f bi-directional guiding sheath ¿ small was being used on the patient.Air did not enter the patient¿s body.This issue did not require percutaneous or surgical removal.No medical intervention was required to stop the bleeding.

Manufacturer Narrative

It was reported that a patient underwent a cardiac ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ small and a hemostatic valve separation occurred.It was reported there was a hemostatic valve defect.There were no patient consequences.Blood came out of the valve.Back bleeding was noticed due to valve probably being dislodged.The hemostatic valve (gasket) did not break into two or more separate pieces, and it did not become detached from the sheath.The carto vizigo¿ 8.5f bi-directional guiding sheath ¿ small was being used on the patient.Air did not enter the patient¿s body.This issue did not require percutaneous or surgical removal.Device evaluation details: the product was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.Visual inspection of the returned device was performed following bwi procedures.Visual analysis revealed that the hemostatic valve was not found inside the device.The hemostatic valve detachment could be related to the dilator wrongly introduced; however, this could not be conclusively determined.A device history record was performed for the finished device batch number, and no internal actions were identified.The issue reported by the customer was confirmed.The odp (optimal device performance guide) contains the following caution: always insert a dilator straight into the center of the sheath¿s valve to prevent damage to the valve.Do not insert a dilator at an angle, as damage to the sheath valve may occur.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

• Brand Name: CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ SMALL
• 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: 15324849
• MDR Text Key: 305375890
• Report Number: 2029046-2022-02042
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835016253
• UDI-Public: 10846835016253
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/30/2023
• Device Model Number: D138501
• Device Catalogue Number: D138501
• Device Lot Number: 00001951
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2022
• 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