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

Model Number D138501

Device Problem Backflow (1064)

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

Event Date 11/26/2020

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 - small where air was drawn through the hemostatic valve.It was reported that carto vizigo¿ 8.5f bi-directional guiding sheath - small could not be aspirated and drew air.Carto vizigo¿ 8.5f bi-directional guiding sheath - small was replaced to complete the procedure without patient consequence.

Manufacturer Narrative

On (b)(6) 2020, the bwi product analysis lab received the complaint device for evaluation.The product 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 ref.# (b)(4).

Manufacturer Narrative

It was reported that carto vizigo¿ 8.5f bi-directional guiding sheath - small could not be aspirated and drew air.Carto vizigo¿ 8.5f bi-directional guiding sheath - small was replaced to complete the procedure without patient consequence.Device evaluation details: the device evaluation has been completed.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.These findings were reviewed and determined the issue of hemostatic valve separation continues to be deemed mdr reportable.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 and all acceptance records demonstrate that the device was manufactured in accordance with device master record.The issue reported by the customer was confirmed.The root cause was a hemostatic valve detachment could be related to the incorrect insertion of the dilator into the sheath causing the dislodgment of the hemostatic valve, since a stress mark and physical damage on the outer diameter were observed under microscope which suggest that excessive force was applied.Due to the conditions observed in the hemostatic valve, an internal corrective action has been open to address this issue.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Note: during product evaluation/testing, the lot number was identified by electronically erasable programmable read only memory (eeprom) as 00001427.As such, field d4.Lot number has been populated.Manufacturer's ref.#(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: 11053554
• MDR Text Key: 229528123
• Report Number: 2029046-2020-01972
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/25/2021
• Device Model Number: D138501
• Device Catalogue Number: D138501
• Device Lot Number: 00001427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2020
• Date Manufacturer Received: 01/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8.5F SHEATH WITH CURVE VIZ SMC