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 11/16/2021

Event Type  malfunction  

Event Description

A patient underwent an atrial fibrillation (afib) procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium for which biosense webster¿s product analysis lab (pal) identified a hemostatic valve separation issue.It was initially reported by the customer that the dilator would not go all the way through the vizigo¿ sheath.The vizigo¿ sheath was replaced and the issue was resolved.The case continued.There was no patient consequence.This customer¿s reported issue of an ¿obstructed sheath¿ was assessed as not mdr reportable since there is evidence of a product malfunction, as the device failed to meet its performance specification or otherwise performed as intended, however the potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.On (b)(6) 2022, the pal revealed that a visual inspection of the device found the hemostatic valve was dislodged inside of the hub of the vizigo sheath.This finding was reviewed and assessed this finding as an mdr reportable malfunction.This event was originally considered non-reportable, however, bwi became aware of a reportable malfunction through visual analysis on 14-jan-2022 and reassessed it as mdr reportable.

Manufacturer Narrative

Device evaluation details: the product was returned to biosense webster inc.(bwi) for evaluation and the evaluation has been completed.Bwi then conducted a visual inspection and microscopic examination of the returned device.Visual analysis of the returned sample revealed that the hemostatic valve was found dislodged inside of the hub of the vizigo sheath.Microscopic examination in the hemostatic valve surface has shown evidence of stress marks on the outer diameter.The brim cap and the silicone ring were placed in the correct position and found in good conditions.The hemostatic valve could cause the obstruction or resistance with sheath felt by the physician.A device history record was performed, and no internal actions related to the reported complaint were identified.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.However, due to the conditions observed in the hemostatic valve, an internal corrective action has been opened to address this issue.It should be noted that product failure is multifactorial.Based on the information currently available, a microscopic examination of the returned product indicates that 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, the stress marks, and physical damage observed 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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

• Brand Name: CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM
• 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: 13354620
• MDR Text Key: 289326769
• Report Number: 2029046-2022-00157
• 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: 01/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2022
• Device Model Number: D138502
• Device Catalogue Number: D138502
• Device Lot Number: 50000030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2021
• Date Manufacturer Received: 01/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2021
• 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: 8.5F SHEATH WITH CURVE VIZ MDC