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

Model Number D138502

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 11/10/2020

Event Type  malfunction  

Manufacturer Narrative

Device investigation details: on 11/13/2020, bwi received photographs of the complaint device.The brim cap appeared detached from the hub, and the brim cap was observed in the pouch.On 12/9/2020, the complaint device was received at the bwi product analysis lab.The device was inspected and it was found the hemostatic valve and the brim cap were missing so that no more analysis could be performed.A device history record evaluation was performed for the finished device number 00001104, and no internal action related to the complaint was found during the review.The issue reported by the customer was confirmed.The root cause of the issue cannot be determined since the brim cap was not returned and no analysis could be performed.Based on the information available, there is evidence that the device 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 before opening the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium sterile package, it was noticed the orange hub was detached from the sheath.There were pieces floating around the inside of the sterile packaging.The package was not opened, and the sheath was replaced.The atrial fibrillation (afib) procedure was continued with the replacement sheath.No patient consequences were reported.Brim cap detachment is an mdr-reportable 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: 11053924
• MDR Text Key: 234832005
• Report Number: 2029046-2020-01973
• 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: 11/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/27/2021
• Device Model Number: D138502
• Device Catalogue Number: D138502
• Device Lot Number: 00001104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2020
• Initial Date Manufacturer Received: 11/13/2020
• Initial Date FDA Received: 12/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2019
• 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