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

Model Number D138502

Device Problems Material Separation (1562); Device Contamination with Body Fluid (2317)

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

Event Date 10/05/2021

Event Type  malfunction  

Event Description

It was reported that a patient underwent an ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium and a clot issue occurred.Carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium was in the left atrium.The physician could not aspirate the sheath.He pulled the sheath out of the body and then tried to flush the sheath.It was then they noticed there was a large clot blocking the hemostatic valve.Carto vizigo¿ 8.5f bi-directional guiding sheath - medium was replaced with a new one.A therapeutic dose of heparin was given by the anesthetist prior to the transseptal puncture.The procedure was delayed due to the reported event for 5 minutes.No patient consequence was reported.Additional information: this issue occurred prior to an ablation catheter being used.The sheath was being used with the pentaray catheter.The system did not present any error messages.There was no obvious issues with the carto vizigo¿ 8.5f bi-directional guiding sheath - medium.The patient was anticoagulated.The physician aimed for an act of 300.This was managed by the anesthetist.The sheath still has the clot in the valve.The patient has not exhibited any neurological symptoms since the procedure was completed.The clot issue was assessed as mdr reportable.

Manufacturer Narrative

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

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 28-dec-2021.Initially this event was assessed for a mdr reportable clot issue.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 06-jan-2022 the visual analysis revealed that the valve was missing, also the device had two bents and the dilator was not included for analysis.The decontamination site reported that the clot inside the device was visualized but later lost during the decontamination process.The returned condition of the clot issue remains mdr reportable.The returned condition of the valve missing was assessed as mdr reportable for a hemostatic valve separation issue.The awareness date for this additional reportable finding is 06-jan-2022.The returned condition of the bents were assessed as not mdr reportable.Device integrity maintained and no internal components exposed to patient.The most likely consequence was an intraprocedural delay.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote.The device evaluation was completed on 06-jan-2022.It was reported that a patient underwent an ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium.Carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium was in the left atrium.The physician could not aspirate the sheath.He pulled the sheath out of the body and then tried to flush the sheath.It was then they noticed there was a large clot blocking the hemostatic valve.Carto vizigo¿ 8.5f bi-directional guiding sheath - medium was replaced with a new one.A therapeutic dose of heparin was given by the anesthetist prior to the transseptal puncture.The procedure was delayed due to the reported event for 5 minutes.No patient consequence was reported.Additional information: this issue occurred prior to an ablation catheter being used.The sheath was being used with the pentaray catheter.The system did not present any error messages.There was no obvious issues with the carto vizigo¿ 8.5f bi-directional guiding sheath - medium.The patient was anticoagulated.The physician aimed for an act of 300.This was managed by the anesthetist.The sheath still has the clot in the valve.The patient has not exhibited any neurological symptoms since the procedure was completed.The device was returned to biosense webster for evaluation.A visual inspection of the returned device was performed in accordance with bwi procedures.Visual analysis of the returned carto vizigo sheath device revealed that the valve was missing, also the device had two bents and the dilator was not included for analysis.The decontamination site reported that the clot inside the device was visualized but later lost during the decontamination process.The root cause of the blockage with the clot could not be determined as the hemostatic valve could not be found and further analysis could not be performed.The issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4) during an internal review on 24-jan-2022, noted a correction to the 3500a follow-up #1.In this report it was provided that the returned condition of the valve missing was assessed as mdr reportable for a hemostatic valve separation issue.However, the h 6.Medical device problem code of material separation (a0413) was omitted.Therefore, added this code.

• Brand Name: CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - MEDIUM
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (IRVINE); 33 technology drive; irvine CA 92618
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12713647
• MDR Text Key: 281408828
• Report Number: 2029046-2021-01839
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835016277
• UDI-Public: 10846835016277
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K170997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/10/2022
• Device Model Number: D138502
• Device Catalogue Number: D138502
• Device Lot Number: 00001683
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2021
• 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
• Treatment: GENERIC - PENTARAY.; UNKNOWN BRAND SHEATH.