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

Model Number D138502

Device Problem Device Contamination with Body Fluid (2317)

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

Event Date 04/04/2022

Event Type  malfunction  

Event Description

It was reported that a patient underwent a atrial flutter left (l-afl) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium and blood clots were found in the sheath.It was reported that during the procedure the physician noted that "something about the vizigo sheath didn't seem right." it seemed as though there might have been an issue with the valve as it seemed that it was not irrigating properly.The sheath was removed, and force flushed and seemed to work properly.However, it was discovered "a few days after" the procedure that the lab team reported that the irrigation to the sheath had been shut off during the procedure.The caller noted there were blood clots in the sheath of the catheter.The sheath was not replaced as they were done using it by the time the issue was noticed.The clot was noticed after the completion of the case when the physician force flushed the sheath on the table.The physician, however, did not mention this to the lab staff or the clinical covering the case.There was no alert from the smartablate irrigation pump.The irrigation pump was connected to the ablation catheter, which had no issues throughout the duration of the procedure.The physician did not feel resistance between the catheter and the sheath.The system did not present any error messages and the physician/user did not see any product problem.There were no issues related to temperature and flow on the catheter.The smartablate generator parameters were power control mode and default settings.The patient was anticoagulated while on the left side of the heart the patient was anticoagulated with target act of at least 300.The patient has not exhibited any neurological symptoms since the procedure was completed.The patient was discharged the same day and no issues related to the procedure were exhibited.The sheath is not available for return.The irrigation issue mentioned is not being coded as it was reported that ¿it was discovered a few days after" the procedure that the lab team reported that the irrigation to the sheath had been shut off during the procedure,¿ therefore, no malfunction has been reported regarding irrigation since it was turned off by staff in error.

Manufacturer Narrative

Device investigation details: the device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.This report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster inc., or its employees that the report constitutes an admission that the product, biosense webster inc., or its employees caused or contributed to the potential event described in this report.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).

• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14520296
• MDR Text Key: 294535978
• Report Number: 2029046-2022-01145
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835016277
• UDI-Public: 10846835016277
• 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: 05/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D138502
• Device Catalogue Number: D138502
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: SMARTABLATE GENERATOR SPARE-US; SMARTABLATE PUMP KIT-US; UNK_PENTARAY; UNK_SMART TOUCH BIDIRECTIONAL SF; UNK_SOUNDSTAR