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 01/26/2020

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2020, the bwi product analysis lab discovered the hemostatic valve dislodgement.The product investigation was subsequently completed.Device evaluation details: the device was visually inspected, and the hemostatic valve was found dislodged into the hub.It was determined that the issue observed could be related to the incorrect insertion of the dilator into the sheath causing the dislodgment of the valve and obstruction since stress marks and physical damage on the outer diameter were observed under microscope which suggest that excessive force was applied.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.A device history record evaluation was performed for the finished device 00001425 number, and no internal action related to the complaint was found during the review.The issue reported by the customer was confirmed.And it appears to be related to the incorrect introduction of the vessel dilator.The odp (optimal device performance guide) provide additional instructions on how to insert the dilator into the sheath.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

A patient underwent an ablation procedure for atrial fibrillation (afib) with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium for which biosense webster¿s product analysis lab identified that the hemostatic valve was dislodged inside of the hub.During the procedure, noise was being displayed by the 12 lead body surface ecg cable.There was noise on the carto 3 system and the recording system.The cable was exchanged and the issue was resolved.Additionally, the dilator of the vizigo sheath would not advance.The sheath was exchanged and the issue resolved.No patient consequences were reported.The noise issue is not mdr-reportable.The dilator obstruction is not mdr-reportable.The hemostatic valve dislodgment is mdr-reportable.

• Brand Name: CARTO VIZIGO 8.5F BI-DIRECTIONAL GUIDING SHEATH MEDIUM
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 11086106
• MDR Text Key: 246073340
• Report Number: 2029046-2020-02000
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/20/2021
• Device Model Number: D138502
• Device Catalogue Number: D138502
• Device Lot Number: 00001425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2020
• Date Manufacturer Received: 12/07/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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