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

Model Number D138501

Device Problems Material Separation (1562); Obstruction of Flow (2423)

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

Event Date 01/01/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The biosense webster, inc.Product analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.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 patient underwent an atrial fibrillation (afib) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ small and a hemostatic valve separation issue occurred.It was not possible to insert the dilator into the sheath.Visible damage (displacement) of sheath's valve.The part that was separated was the transparent valve of the sheath, a white part (probably the entering part of the valve) was visible.It was probably pushed into the transparent part.The sheath was not used on the patient because of a complete block and the dilator was not insertable.Therefore, the sheath was not used on the patient.This sheath was replaced with another one and from the same type, so that procedure was ended successfully.There were no patient consequences.

Manufacturer Narrative

The device evaluation was completed on 11-mar-2022.It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ small and a hemostatic valve separation issue occurred.It was not possible to insert the dilator into the sheath.Visible damage (displacement) of sheath's valve.The part that was separated was the transparent valve of the sheath, a white part (probably the entering part of the valve) was visible.It was probably pushed into the transparent part.The sheath was not used on the patient because of a complete block and the dilator was not insertable.Therefore, the sheath was not used on the patient.This sheath was replaced with another one and from the same type, so that procedure was ended successfully.There were no patient consequences.Device evaluation details: the product was returned to biosense webster inc.(bwi) for evaluation.Bwi then conducted a visual inspection and microscopic examination of the returned device.Visual analysis of the returned sheath revealed that the hemostatic valve was not found on the hub component nor inside the sheath.The brim cap and silicone ring were found in normal condition.The vizigo¿ shaft was inspected, and it was found in normal condition.The dilator was found in normal condition.Microscopic examination showed that the silicone ring was placed in the correct position and found in good conditions.It should be noted that product failure is multifactorial.Based on the information currently available, the hemostatic valve could have been detached due to the dilator being wrongly introduced; however, this could not be conclusively determined since the valve was not returned for analysis.According to the odp (optimal performance guide), there are some precautions on inserting the dilator into the vizigo sheath: ¿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.¿ the device history record (dhr) for the lot number 00001745 has been received and no internal actions related to the complaint were found during the review.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 reference number: (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) on 22-jan-2024, the h6.Investigation conclusions code was corrected from cause traced to user (d11) to unintended use error caused or contributed to event (d1102).

• 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13608008
• MDR Text Key: 289327623
• Report Number: 2029046-2022-00386
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/04/2022
• Device Model Number: D138501
• Device Catalogue Number: D138501
• Device Lot Number: 00001745
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/31/2022
• Initial Date FDA Received: 02/25/2022
• Supplement Dates Manufacturer Received: 03/11/2022; 01/22/2024
• Supplement Dates FDA Received: 04/08/2022; 01/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2021
• 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
• Treatment: UNK BRAND SHEATH