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

Model Number D138501

Device Problems Material Separation (1562); Detachment of Device or Device Component (2907)

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

Event Date 11/25/2020

Event Type  malfunction  

Manufacturer Narrative

The product has not returned for analysis, however, pictures were provided by the customer.Evaluation is still in progress.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.Manufacturer's reference number: (b)(4).

Event Description

It was reported that during an atrial fibrillation (afib) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath - small, a hemostatic valve separation and brim cap detachment issues occurred.There was backflow blood through the hemostatic valve of the carto vizigo¿ 8.5f bi-directional guiding sheath - small.The hemostatic valve did not break into two or more separate pieces.The hemostatic valve did not become detached from the sheath.Patient¿s hemodynamics was not compromised due to the issue experienced.No interventions were required to stop the bleed.No air entered the patient¿s body.The sheath was replaced, and the issue resolved.Since patient¿s hemodynamics was not compromised and no interventions were required, this event was not assessed as a patient event but as a mdr reportable product malfunction for a "hemostatic valve-separation" since it is most likely the blood leakage occurred due to a malfunctioning/dislodged valve.In addition, the pictures received were reviewed.The pictures revealed the orange brim cap was missing; therefore, this event was also assessed as a mdr reportable brim cap detached issue.

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 12/23/2020.H6. investigation findings code and h6.Component code of ¿appropriate term/code not available¿ represents photo/video analysis.  the investigation summary was completed on (b)(6)2021.It was reported that during an atrial fibrillation (afib) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath - small, a hemostatic valve separation and brim cap detachment issues occurred.There was backflow blood through the hemostatic valve of the carto vizigo¿ 8.5f bi-directional guiding sheath - small.The hemostatic valve did not break into two or more separate pieces.The hemostatic valve did not become detached from the sheath.Patient¿s hemodynamics was not compromised due to the issue experienced.No interventions were required to stop the bleed.No air entered the patient¿s body.The sheath was replaced, and the issue resolved.In addition, the pictures received were reviewed.The pictures revealed the orange brim cap was missing.An analysis was performed on the pictures that were provided by the customer.According to the pictures, the hub was observed without the brim cap and hemostatic valve.The customer complaint was confirmed based on the picture received.The product analysis was performed as appropriate in order to find root cause of the complaint.The returned device was visually inspected and the brim cap, the hemostatic valve and silicone ring were not returned with the device.No other damages were observed on the device.Adhesive was normally applied to bond the clear hub and the brim cap.A device history 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 brim cap issue cannot be related to the manufacturing process since there is evidence that the device was manufactured in accordance with documented specification and procedures.It could be related to the handling of the device during the procedure.However, this cannot be conclusively determined.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 SMALL
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 11041718
• MDR Text Key: 245044494
• Report Number: 2029046-2020-01963
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835016253
• UDI-Public: 10846835016253
• 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: 11/25/2020

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: Health Professional
• Device Expiration Date: 01/02/2021
• Device Model Number: D138501
• Device Catalogue Number: D138501
• Device Lot Number: 00001080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2020
• Initial Date Manufacturer Received: 11/25/2020
• Initial Date FDA Received: 12/18/2020
• Supplement Dates Manufacturer Received: 12/23/2020
• Supplement Dates FDA Received: 01/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN BRAND SHEATH