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

Model Number D138502

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

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

Event Date 03/15/2022

Event Type  malfunction  

Manufacturer Narrative

The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Investigation is in progress, once completed a supplemental will be submitted.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 an atrial fibrillation (afib) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium and a hemostatic valve separation occurred.The dilator of the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium would not advance into the sheath and the valve broke.The sheath was exchanged, and the issue was resolved.The case continued without any further incident.There was no patient consequence.Additional information was received indicated the hemostasis valve was pushed into the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium.The hemostatic valve did become detached from the sheath it was pushed deeper into sheath.The sheath was not being used on the patient.It was never introduced into patient, issues occurred during preparation.The customer¿s reported issue of being unable to advance the dilator (obstructed sheath) is not considered to be mdr reportable since the potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.This event is reportable for the hemostatic valve separation.

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium and a hemostatic valve separation occurred.The dilator of the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium would not advance into the sheath and the valve broke.The sheath was exchanged, and the issue was resolved.The case continued without any further incident.There was no patient consequence.Device evaluation details: the device investigation has been completed which included a device history record (dhr) review.The dhr review performed for the finished device with lot # 50000078, found no internal actions related to the complaint during the review.Still no device has been received for analysis, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Based on the completed mre, the h4.Device manufacture date has been populated with 09-jan-2022.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 ¿ MEDIUM
• 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 ; 6465917981
• MDR Report Key: 14046180
• MDR Text Key: 289754230
• Report Number: 2029046-2022-00748
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835016277
• UDI-Public: 10846835016277
• 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
• Report Date: 05/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/09/2023
• Device Model Number: D138502
• Device Catalogue Number: D138502
• Device Lot Number: 50000078
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2022
• 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
• Treatment: CARTO 3 SYSTEM.; THMCL SMTCH SF BID, TC, F-J.