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

Model Number D138501

Device Problems Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)

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

Event Date 03/23/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone: (b)(6).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 sample revealed that the hemostatic valve was dislodged inside the hub of the carto vizigo.Bent conditions were observed along the shaft, and the dilator.Examination of the brim cap and the silicone ring revealed the components were placed in the correct position and found in good condition.A functional test was performed, in accordance with bwi procedures.The vessel dilator and stsf catheter were introduced into the vizigo sheath and some resistance was felt during the testing.The od vessel dilator was measured, and it was within specifications.The issue reported by the customer was confirmed.The odp (optimal device performance guide) contains the following caution: 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.A device history record review was performed for the finished device 00001827 number, and no internal actions related to the complaint were found during the review.Additional investigation was initiated to address the root cause of the resistance to sheath issues and for the hemostatic valve dislodgment.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 a cardiac ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath - small and the biosense webster inc, (bwi) product analysis lab observed that the hemostatic valve was dislodged inside the hub of the carto vizigo¿.Initially, it was reported that before the procedure, when the dilator attached to the vizigo¿ sheath was inserted, the dilator did not fit because it was ¿astringent¿.The dilator could not get into the vizigo¿ even after careful water flush was performed again, so the sheath was replaced for handling.¿the procedure was handled with temporary tape¿.The procedure was successfully completed without patient consequence.The issue of resistance with sheath was assessed as not mdr reportable.Interference or friction between devices is a known occurrence.If resistance is encountered, the system may be withdrawn as a unit.This is a common practice during procedures.This event is being reported because the biosense webster inc, (bwi) product analysis lab received the device for evaluation and found the hemostatic valve to be dislodged inside the hub of the carto vizigo¿.The awareness date for this reportable lab finding is 17-jun-2022.

• 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: 15010718
• MDR Text Key: 303068940
• Report Number: 2029046-2022-01609
• 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
• Report Date: 07/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/22/2022
• Device Model Number: D138501
• Device Catalogue Number: D138501
• Device Lot Number: 00001827
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2022
• Date Manufacturer Received: 06/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2021
• 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: SMARTABLATE GEN. KIT (JAPAN); SMARTABLATE PUMP KIT (JAPAN); UNK BRAND SHEATH