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

Model Number D138502

Device Problem Material Separation (1562)

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

Event Date 12/03/2020

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a patient underwent cardiac ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium where hemostatic valve separation occurred.It was reported by the caller the valve of the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium was leaking blood when it was inserted into the patient.The sheath was exchanged with a competitor sheath and the issue was resolved.The case was completed.There was no report of patent consequence.No air entered the patient¿s body.This issue did not require percutaneous or surgical removal.The blood loss was 10-20ml, the hemodynamics was not compromised due to bleeding and no intervention was required.Since the patient¿s hemodynamics was not compromised and no interventions were required to stop the bleed, this will not be considered a patient adverse event but a product malfunction.

Manufacturer Narrative

It was reported by the caller the valve of the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium was leaking blood when it was inserted into the patient.The sheath was exchanged with a competitor sheath and the issue was resolved.The case was completed.There was no report of patent consequence.No air entered the patient¿s body.This issue did not require percutaneous or surgical removal.The blood loss was 10-20ml, the hemodynamics was not compromised due to bleeding and no intervention was required.Device evaluation details: on 1/13/2021, the bwi product analysis lab received the complaint device for evaluation.A visual inspection was performed to the device and it was found that the hemostatic valve is dislodged inside the hub of the device.The issue could be related to the incorrect insertion of the dilator into the sheath causing the dislodgment of the valve 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 was performed and no internal action related to the reported complaint were identified.The customer complaint was confirmed.The root cause of the dislodged hemostatic valve inside the hub could be related to handling of the device during the procedure however, this cannot be conclusively determined.The odp (optimal device performance guide) provide additional instructions on how to insert the dilator into the sheath.Due to the conditions observed in the hemostatic valve, an internal corrective action has been open to address this issue.Additionally the customer had also provided a picture of the complaint device to aid in the investigation.According to pictures provided by customer, hemostatic valve was observed dislodged in the hub.The customer's complaint was also confirmed based on the picture received.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (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: 11099729
• MDR Text Key: 252617518
• Report Number: 2029046-2020-02025
• 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: 12/03/2020

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: 09/23/2021
• Device Model Number: D138502
• Device Catalogue Number: D138502
• Device Lot Number: 00001466
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2021
• Initial Date Manufacturer Received: 12/03/2020
• Initial Date FDA Received: 12/31/2020
• Supplement Dates Manufacturer Received: 01/13/2021
• Supplement Dates FDA Received: 01/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NON-BWI (COMPETITOR) SHEATH