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); Device-Device Incompatibility (2919)

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

Event Date 08/02/2022

Event Type  malfunction  

Manufacturer Narrative

(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.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.When inserting the dilator from the hemostatic valve, the dilator did not move forward.This occurred after the patient entry to the room and before puncture.The issue was resolved by changing the sheath to a new one.The hemostatic valve fell/detached into the hub.The hemostatic valve was not cracked.The procedure was completed without patient consequence.The obstructed sheath was assessed as not mdr reportable.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.The hemostatic valve separation was assessed as a mdr reportable product malfunction.There is potential for significant bleeding or air embolism that might require additional intervention to prevent serious injury or death.

Manufacturer Narrative

On (b)(6) 2022, 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.Additional information was received on 16-sep-2022.There was resistance while trying to advance the dilator into the sheath.There was no occlusion when irrigating the sheath.The sheath was neither narrowed, nor partially blocked, nor completely blocked.The physician was not able to move forward dilator, but was able to withdraw it.The hemostatic valve (gasket) did not break into two or more separate pieces.The hemostatic valve/brim cap/hub did not become detached from the sheath.Based on the additional information received, the h6.Medical device problem code was updated.The code of obstruction of flow (a1409) was replaced with device-device incompatibility (a1702).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 01-oct-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.When inserting the dilator from the hemostatic valve, the dilator did not move forward.This occurred after the patient entry to the room and before puncture.The issue was resolved by changing the sheath to a new one.The hemostatic valve fell/detached into the hub.The hemostatic valve was not cracked.The procedure was completed without patient consequence.Device evaluation details: the product was returned to biosense webster (bwi) for evaluation.Visual and dimensional inspections of the returned device were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the sheath nor valve; however, dilator was not returned for analysis.A dilator and a good known lab sample catheter were introduced through the sheath, and resistance was felt.No obstructions were detected.A device history record (dhr) review was performed for the finished device number 00001904 and no internal action related to the complaint was found during the review.Based on the dhr, the h4.Device manufacture date has been updated.The resistance issue reported by the customer was confirmed.This product issue will be addressed through bwi¿s quality system.An internal corrective action has been opened to investigate this issue.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi's quality system.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: 15312841
• MDR Text Key: 305505664
• Report Number: 2029046-2022-02024
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2023
• Device Model Number: D138501
• Device Catalogue Number: D138501
• Device Lot Number: 00001904
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2022
• 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
• Treatment: UNK BRAND SHEATH.