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

Model Number D138501

Device Problem Material Separation (1562)

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

Event Date 12/02/2020

Event Type  malfunction  

Manufacturer Narrative

The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A device history record evaluation was performed for the finished device [00001467] number, and no internal action related to the reported complaint condition were identified.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 an atrial fibrillation (afib) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ small and a hemostatic valve separation occurred.It was reported that the hemostatic valve on the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ small was leaking back blood.Blood leak was minimal, 5-10cc.Hemodynamics were not compromised.The sheath was being used on the patient and did not break, it leaked.The valve did not become detached and no medical intervention was required to stop the bleed.The sheath was replaced, and the issue was resolved.With the available information, this event is being assessed as a ¿hemostatic valve separation¿ as it is most likely the backflow blood was due to a malfunctioning or dislodged valve.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.

• 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
• Manufacturer (Section G): BIOSENSE WEBSTER INC (IRVINE); 33 technology drive; irivine CA 92618
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 11099158
• MDR Text Key: 229527103
• Report Number: 2029046-2020-02020
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835016253
• UDI-Public: 10846835016253
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/02/2020

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: D138501
• Device Catalogue Number: D138501
• Device Lot Number: 00001467
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/02/2020
• Initial Date FDA Received: 12/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1