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 08/01/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter name and address: phone: (b)(6).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.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 ¿ small.The hemostatic valve was detached into the hub.During preparation for puncture when the dilator was going to be inserted into the vizigo, the dilator could not be inserted.The hemostatic valve detached into the hub.The hemostatic valve was not cracked.The issue was resolved by changing the sheath to another new one.The procedure was completed without patient's consequence.Obstructed sheath is not mdr-reportable.Hemostatic valve separation is mdr-reportable.

Manufacturer Narrative

On (b)(6) 2022, the bwi 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).

Manufacturer Narrative

On 28-oct-2022, the product investigation was completed.Device evaluation details: visual inspection, dimensional inspection, and functional test were performed on the returned device following bwi procedures.The vizigo sheath and the vessel dilator were visually inspected, and the dilator was in a kinked condition, no other damages or anomalies were observed on them.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 functional test was performed by inserting a lab sample catheter through the sheath, resistance was felt during the advancement, although resistance was felt, no obstructions were detected during the test.The dilator's outer diameter was measured, and dimensions were found within specifications.The kinked condition observed on the dilator could be related to the handling of the device during the procedure since according to the information provided the dilators were bent while trying to push them upon meeting resistance.It should be noted that product failure could be caused by multiple factors.The optimal device performance guide (odp) does contain the following recommendations: 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.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 issue reported by the customer was confirmed.Due to the resistance with sheath issue, an internal action was opened.A device history record evaluation was performed for finished device number 00001964 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 ¿ 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: 15263579
• MDR Text Key: 305249384
• Report Number: 2029046-2022-01925
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835016253
• UDI-Public: 10846835016253
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup,Followup
• Report Date: 11/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/09/2023
• Device Model Number: D138501
• Device Catalogue Number: D138501
• Device Lot Number: 00001964
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2022
• 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