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

Model Number D138502

Device Problem Material Perforation (2205)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/20/2019

Event Type  malfunction  

Manufacturer Narrative

The biosense webster, inc.Product analysis lab received the device for evaluation.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.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 a paroxysmal atrial fibrillation (afib) procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium and the sheath was perforated by the dilator.It was reported that the dilator came out of the irrigation hole and dilated the irrigation hole.The carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium was replaced and the issue was resolved.The carto 3 system was operating per specifications and was not responsible for the product issue.They reported that the sheath has been determined to be the root cause of the complaint.The procedure was continued.There was no report of patient consequence.The perforation of the sheath by the dilator was assessed as a reportable malfunction.

Manufacturer Narrative

Investigation summary: it was reported that a patient underwent a paroxysmal atrial fibrillation (afib) procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium.It was reported that the dilator came out of the irrigation hole and dilated the irrigation hole.The carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium was replaced and the issue was resolved.The carto 3 system was operating per specifications and was not responsible for the product issue.They reported that the sheath has been determined to be the root cause of the complaint.The procedure was continued.There was no report of patient consequence.The device was visually inspected and one of the irrigation holes was found damaged.This damage occurred during the procedure.A manufacturing record evaluation was performed and no internal actions related to the reported complaint were identified.The customer complaint was confirmed.The root cause of the irrigation hole damage was related to the procedure since it was reported that the dilator came out of the irrigation hole.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.No: (b)(4).

Manufacturer Narrative

During the initial reported event, the dilator came out of the irrigation hole and dilated the irrigation hole.During the first visual performed by the biosense webster, inc.Product analysis lab, no visual damage or anomalies were observed on the device.During additional assessment on january 16, 2020, the biosense webster, inc.Product analysis lab noted that the device was found with the dilator inside.Visual inspection revealed a damaged irrigation hole.This finding remains reportable.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer¿s reference number: (b)(4).

Manufacturer Narrative

During additional assessment, it was determined on august 14, 2020 that the most probable outcome of this failure mode is a procedure delay.Therefore, there was no risk to the patient.This event was reassessed from mdr reportable to not mdr reportable.Manufacturer¿s reference number: (b)(4).

• 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
• MDR Report Key: 9588160
• MDR Text Key: 196075137
• Report Number: 2029046-2020-00092
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835016277
• UDI-Public: 10846835016277
• 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,Followup,Followup
• Report Date: 12/20/2019

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: Health Professional
• Device Expiration Date: 08/14/2020
• Device Model Number: D138502
• Device Catalogue Number: D138502
• Device Lot Number: 00001175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2020
• Initial Date Manufacturer Received: 12/20/2019
• Initial Date FDA Received: 01/14/2020
• Supplement Dates Manufacturer Received: 01/16/2020; 02/10/2020; 08/14/2020
• Supplement Dates FDA Received: 01/29/2020; 02/11/2020; 09/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM.; UNKNOWN BRAND SHEATH.