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

Model Number D138503

Device Problems Partial Blockage (1065); Fluid/Blood Leak (1250)

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

Event Date 12/14/2021

Event Type  malfunction  

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).

Event Description

It was reported that a patient underwent an afib ¿ persistent ablation procedure with carto vizigo¿ 8.5f bi-directional guiding sheath ¿ large and the hemostatic valve was leaking and the sheath was not irrigating properly.It was reported that when flushing the vizigo sheath, the hemostatic valve was leaking back, and the sheath was not irrigating properly.The vizigo sheath was replaced, and the issue resolved.The procedure continued.No adverse patient consequence was reported.Additional information was received on 23-dec-2021.The physician noticed the irrigation issue when they went to flush the sheath and the fluid came directly back out.The physician did not feel resistance between the catheter and the sheath.The issue was resolved by opening a new sheath.

Manufacturer Narrative

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).

Manufacturer Narrative

The device evaluation was completed on (b)(6)-2022.It was reported that a patient underwent an afib ¿ persistent ablation procedure with carto vizigo¿ 8.5f bi-directional guiding sheath ¿ large and the hemostatic valve was leaking and the sheath was not irrigating properly.It was reported that when flushing the vizigo sheath, the hemostatic valve was leaking back, and the sheath was not irrigating properly.The physician noticed the irrigation issue when they went to flush the sheath and the fluid came directly back out.The physician did not feel resistance between the catheter and the sheath.The vizigo sheath was replaced, and the issue resolved.The procedure continued.No adverse patient consequence was reported.Device evaluation details: the product was returned to biosense webster inc.(bwi) for evaluation.Bwi conducted a visual inspection and an evaluation of the backpressure test of the vizigo¿ sheath.Visual analysis of the returned product revealed that no damage or anomalies were observed on the vizigo¿ sheath.Per the event, irrigation, flow and pressure tests were performed, in accordance with bwi procedures, and no issues were observed.Values were observed within specifications.A device history record (dhr) was performed for the finished device 00001823 number, and no internal actions related to the complaint was found during the review.Based on the dhr, the h4.Device manufacture date has been updated.No malfunction was observed during the product analysis.The instructions for use contain the following recommendations: 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.Flush and maintain continuous saline.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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13202463
• MDR Text Key: 286328836
• Report Number: 2029046-2022-00055
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835016260
• UDI-Public: 10846835016260
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/19/2022
• Device Model Number: D138503
• Device Catalogue Number: D138503
• Device Lot Number: 00001823
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2021
• 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: THMCL SMTCH SF BID, TC, D-F; UNKNOWN BRAND SHEATH