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

Model Number D138502

Device Problems Obstruction of Flow (2423); Detachment of Device or Device Component (2907)

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

Event Date 10/05/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluation was completed on 12/3/2020.Sheath was inspected, and visual analysis revealed that hemostatic valve appears dislodged inside of hub.Brim cap and friction ring remain intact.It was determined that the issue observed could be related to the incorrect insertion of the dilator into the sheath causing the dislodgment.A device history record (dhr) was performed, and no internal action related to the complaint was found during the review.Customer complaint was confirmed.The root cause of the damage on the hemostatic valve inside the hub could be related with the excessive force and handling of the sheath during the procedure, however, this cannot be conclusively determined.The odp (optimal device performance guide) provides additional instructions on how to insert the dilator into the sheath.In addition, there is evidence that the sheath was manufactured in accordance with documented specification and procedures.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

It was reported that a patient underwent a paroxysmal atrial fibrillation (afib) procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath, medium, and the biosense webster, inc.Product analysis lab observed a hemostatic valve separation issue.Initially it was reported that there was a visible obstruction in the hemostatic valve of the carto vizigo¿ 8.5f bi-directional guiding sheath, medium, making it impossible to advance the dilator.This was noticed when removed from the packaging.The sheath was exchanged to continue the case.There was no patient consequence reported.Additional information received clarified that the device was used in the patient.The obstructed sheath was assessed as not mdr reportable.The potential that it could cause or contribute to a death, serious injury, or other significant adverse event, was remote.The biosense webster, inc.Product analysis lab received the device for evaluation, and on (b)(6) 2020 it was observed that the hemostatic valve appeared dislodged inside of hub.The brim cap, and friction ring remained intact.The returned condition was assessed as a mdr reportable hemostatic valve separation issue.

• 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 (Section G): BIOSENSE WEBSTER INC (IRVINE); 33 technology drive; irivine CA 92618
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 11037498
• MDR Text Key: 222693684
• Report Number: 2029046-2020-01962
• 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
• Report Date: 10/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/05/2021
• Device Model Number: D138502
• Device Catalogue Number: D138502
• Device Lot Number: 00001246
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2020
• Date Manufacturer Received: 11/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2020
• 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