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

Model Number D138501

Device Problems Material Deformation (2976); Sharp Edges (4013)

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

Event Date 07/12/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The product was returned to biosense webster (bwi) for evaluation on 18-aug-2021.The device evaluation was completed on (b)(6) 2021.Bwi conducted a visual inspection and outer diameter measurement of the returned catheter.Visual analysis of the returned sample was performed and it was found the silicon coating peeled off, and electrode 4 lifted, due to this issue some internal parts were exposed.At this time, it is not possible to determine the root cause of this condition, however, based on the information provided, the condition reported has origin in someplace external to the manufacturing environment.A device history record evaluation was performed for the finished device 00001630 number, and no internal action was found during the review.As part of bwi¿s quality process, all catheters are manufactured, inspected, and released to approved specifications.It should be noted that product failure is multifactorial.According to the odp (optimal performance guide), there are some precautions on the use of the vizigo sheath: inspect all components before use.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(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 and the biosense webster inc, (bwi) product analysis lab observed that the silicon coating peeled off, and electrode 4 lifted, and some internal parts exposed.Initially, it was reported that when the vizigo¿ sheath was removed from the patient¿s body, the electrical potential (electrode) was noted to be deformed.The procedure was completed without any patient consequence.There was no physical damage observed at the distal end of the catheter.There were no sharp or rough edges.There was no foreign material caught in the deformed electrode.The electrode damage without foreign material and without sharp rough edges was assessed as not mdr reportable.Electrode rings are smooth or dull.The most likely consequence is an intraprocedural delay.The potential risk that it could cause or contribute to a serious injury or death is remote.This event is being reported because the biosense webster inc, (bwi) product analysis lab received the device for evaluation and found the silicon coating peeled off, and the electrode 4 lifted, and some internal parts exposed.This finding was assessed as mdr reportable.The device integrity is not maintained and internal components are exposed to patient.Rings edges might be sharp.The awareness date is (b)(6) 2021.

• 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
• MDR Report Key: 12666611
• MDR Text Key: 284177696
• Report Number: 2029046-2021-01770
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835016253
• UDI-Public: 10846835016253
• Combination Product (y/n): N
• PMA/PMN Number: K170997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial
• Report Date: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/21/2022
• Device Model Number: D138501
• Device Catalogue Number: D138501
• Device Lot Number: 00001630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2021
• Date Manufacturer Received: 09/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1