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

Catalog Number D138501

Device Problems Device-Device Incompatibility (2919); Material Integrity Problem (2978)

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

Event Date 11/07/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation was completed on 06-dec-2023.The device was returned to biosense webster (bwi) for evaluation.A visual inspection and microscopic examination of the returned device were performed following bwi procedures.Visual analysis revealed that the hemostatic valve was dislodged inside of hub component.Microscopic examination of the hemostatic valve surface showed stress marks on the outer diameter.The damage observed could be caused by trying to insert the pentaray catheter into the sheath causing the dislodgement of the valve.The stress marks and physical damage observed suggest that excessive force or manipulation was applied; however, this could not be conclusively determined.A device history record was performed for the finished device batch number, and no internal actions were identified.The issues reported by the customer were confirmed.The valve dislodgement could be related to the resistant issue reported by the customer.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.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.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath - small for which biosense webster¿s product analysis lab (pal) identified that the hemostatic valve was dislodged.The pentaray catheter was unable to be advanced into the carto vizigo¿ 8.5f bi-directional guiding sheath - small.They had to apply more pressure and the pentaray catheter splines were damaged.The splines became bent and distorted.The hemostatic valve was not opening and they were not able to manipulate it to allow the catheter to pass through.The carto vizigo¿ 8.5f bi-directional guiding sheath ¿ small was replaced to continue the procedure.They also had to replace the catheter due to the physical damage.No patient consequence reported.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 06-dec-2023, the hemostatic valve was dislodged inside of the hub component.This event was originally considered non-reportable, however, bwi became aware of the hemostatic valve dislodged inside of the hub component on 06-dec-2023 and have assessed this returned condition as reportable.

• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 18438135
• MDR Text Key: 331872620
• Report Number: 2029046-2024-00033
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835016253
• UDI-Public: 10846835016253
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D138501
• Device Lot Number: 60000227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2023
• Initial Date Manufacturer Received: 12/06/2023
• Initial Date FDA Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2023
• 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: PENTARAY NAV ECO 7FR, F, 2-6-2