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

Model Number D138503

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/19/2019

Event Type  malfunction  

Manufacturer Narrative

On 12/4/2019, the biosense webster inc.(bwi) product analysis lab (pal) received the device for evaluation.Upon initial inspection, the pushed in dilator was confirmed and the shaft was observed kinked.The observed kinked shaft has been assessed as not mdr reportable.Further testing was then performed.During a second visual inspection on 12/4/2019, multiple kinks were observed in the shaft 28 cm, 43 cm, 57 cm, and 10 cm¿s from the distal tip.Additionally, the hemostatic valve and friction ring were pushed in.The observed dislodged hemostatic valve has been assessed as an mdr reportable malfunction.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.(b)(4).

Event Description

It was reported that a patient underwent an ablation procedure for atrial fibrillation (a-fib) with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ large, and the dislodged hemostatic valve issue occurred.The hemostatic valve got pushed in by the dilator.Catheter replacement resolved the issue.No adverse patient consequences were reported.The observed dislodged hemostatic valve issue has been assessed as an mdr reportable malfunction as device integrity was maintained.Follow up was performed the clarify additional details.On 12/3/2019, additional information was received indicating minimal blood loss of approximately 5 cc occurred, the hemostatic valve gasket broke into two or more separate pieces, and that the rubber/silicon gasket was detached, but contained inside the valve casing.The observed dislodged hemostatic valve issue has been assessed as an mdr reportable malfunction as device integrity was compromised.The awareness date has been reset to 12/3/2019.

Manufacturer Narrative

It was reported that a patient underwent an ablation procedure for atrial fibrillation (a-fib) with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ large, and the dislodged hemostatic valve issue occurred.The hemostatic valve got pushed in by the dilator.The investigational analysis completed 1/7/2020.The device was visually inspected and multiple kinks were observed along the shaft.Further analysis revealed that the hemostatic valve and friction ring pushed into the hub.A manufacturing record evaluation was performed and no internal actions were identified.Customer complaint was confirmed.The root cause of the separation of the valve and ring cannot be determined.However it could be related to the procedure.Manufacture reference no: (b)(4).

• Brand Name: CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ LARGE
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 9528114
• MDR Text Key: 200013300
• Report Number: 2029046-2019-04072
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835016260
• UDI-Public: 10846835016260
• Combination Product (y/n): N
• PMA/PMN Number: K170997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D138503
• Device Catalogue Number: D138503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2019
• Date Manufacturer Received: 01/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1