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

Model Number D138502

Device Problem Partial Blockage (1065)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/23/2020

Event Type  malfunction  

Manufacturer Narrative

The bwi 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 an idvt cardiac ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath - medium where sheath irrigation issue occurred.It was reported that the carto vizigo¿ 8.5f bi-directional guiding sheath - medium side port was not allowing flush or negative pressure, as if it was occluded.The sheath was exchanged to continue the case successfully.The sheath was not connected to a pump.The physician was trying to manually aspirate side port with a syringe after initial sheath insertion.There was no report of patient consequence.The sheath irrigation issue is mdr-reportable.

Manufacturer Narrative

On (b)(6) 2020, the bwi product analysis lan identified a dislodged hemostatic valve.The product investigation was subsequently completed.It was reported that a patient underwent an idvt cardiac ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath - medium where sheath irrigation issue occurred.It was reported that the carto vizigo¿ 8.5f bi-directional guiding sheath - medium side port was not allowing flush or negative pressure, as if it was occluded.The sheath was exchanged to continue the case successfully.The sheath was not connected to a pump.The physician was trying to manually aspirate side port with a syringe after initial sheath insertion.There was no report of patient consequence.Device evaluation details: the device was visually inspected, and 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 and leaking blood since stress marks and physical damage on the outer diameter were observed under microscope 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.A device history record evaluation was performed for the finished device 00001374 number, and no internal action related to the complaint was found during the review.The issue reported by the customer was confirmed since the issue with the hemostatic valve can be related to the irrigation of the sheath.It seems to be related to the incorrect introduction of the vessel dilator.The odp (optimal device performance guide) provide additional instructions on how to insert the dilator into the sheath.In addition, 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).

• 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: 10837545
• MDR Text Key: 229686484
• Report Number: 2029046-2020-01688
• 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
• Report Date: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/08/2021
• Device Model Number: D138502
• Device Catalogue Number: D138502
• Device Lot Number: 00001374
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2020
• Date Manufacturer Received: 12/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1