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 12/01/2021

Event Type  malfunction  

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 and the biosense webster, inc.Product analysis lab observed a hemostatic valve separation issue.Initially it was reported that there was resistance when trying to insert the dilator into the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ small and they were unable to advance the dilator at all.The carto vizigo¿ 8.5f bi-directional guiding sheath - small was replaced and the issue resolved.The procedure continued.There was no patient consequence reported.Additional information was received on the event.The resistance they were having with the sheath occurred when they were trying to put the dilator into the sheath.They could not see any physical damage on the sheath/dilator.Did not believe the dilator was broken.Can not recall if there was any occlusion when irrigating the sheath.The sheath seemed narrow as they could only fit the dilator partially in.They were only able to move the dilator for the first few mm¿s through the sheath and then it got stuck.The dilator was not stuck on the sheath as they were able to remove the dilator from the sheath.The resistance with sheath issue 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or friction between devices is a known occurrence.If resistance is encountered, the system may be withdrawn as a unit.This is a common practice during procedures.Since the vast majority of ep procedures utilize multiple device exchanges, an increased potential for patient injury is remote.The obstructed sheath issue 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 biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 27-jan-2022, the hemostatic valve was not returned with the carto vizigo sheath.The returned condition was assessed as mdr reportable for a hemostatic valve separation issue.The awareness date for this reportable lab finding was 27-jan-2022.

Manufacturer Narrative

The device evaluation was completed on 27-jan-2022.The product was returned to biosense webster for evaluation.Bwi then conducted a visual inspection of the returned sheath.Visual analysis of the returned sample revealed that the hemostatic valve was not returned with the carto vizigo sheath.Resistance was not felt when the dilator was inserted, the resistance reported in the event could be related to the hemostatic valve separation.A device history record evaluation was performed, and no internal actions were identified.It should be noted that sheath failure is multifactorial.Based on the information currently available, the issue observed could be related to the incorrect insertion of the dilator into the sheath causing the dislodgment of the valve and silicone ring.The dilator was inserted to verify if the valve was inside the sheath, but it was not found.According to the odp (optimal performance guide), there are some precautions on inserting the dilator into the vizigo sheath: ¿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.¿ 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13509661
• MDR Text Key: 289006381
• Report Number: 2029046-2022-00266
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/24/2022
• Device Model Number: D138501
• Device Catalogue Number: D138501
• Device Lot Number: 00001768
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2021
• Date Manufacturer Received: 01/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2021
• 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: UNKNOWN BRAND SHEATH