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 02/04/2020

Event Type  malfunction  

Manufacturer Narrative

Since the product was not returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors could be made.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacture reference no: (b)(4).

Event Description

It was reported that a patient underwent an ablation procedure for atrial fibrillation (afib)with a carto vizigo¿ 8.5f bi-directional guiding sheath - medium, and a perforated dilator issue occurred.During the procedure, the guide became stuck inside one of the irrigation holes of the vizigo, 8.5 fr, medium curve sheath.The sheath was replaced, and the issue resolved.No adverse patient consequences were reported.The observed perforation on the dilator has been assessed as an mdr reportable malfunction.

Manufacturer Narrative

It was reported that a patient underwent an ablation procedure for atrial fibrillation (afib)with a carto vizigo¿ 8.5f bi-directional guiding sheath - medium, and a perforated dilator issue occurred.During the procedure, the guide became stuck inside one of the irrigation holes of the vizigo, 8.5 fr, medium curve sheath.The investigational analysis completed (b)(6) 2020.The device was visually inspected, and it was found in good conditions.The dilator was introduced, and no resistance or friction was not felt when it was advanced through the sheath.A manufacturing record evaluation was performed for the finished device, and no internal actions were found during the review.The customer complaint cannot be confirmed.Manufacture reference no: (b)(4).

Manufacturer Narrative

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.A manufacturing record evaluation was performed for the finished device and no internal actions were found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacture reference no: pc-000652808.

Manufacturer Narrative

During additional assessment, it was determined on (b)(6)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: 9773076
• MDR Text Key: 195717925
• Report Number: 2029046-2020-00327
• Device Sequence Number: 1
• Product Code: LPB
• 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: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D138502
• Device Catalogue Number: D138502
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1