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

Model Number D138503

Device Problem Device Contamination with Body Fluid (2317)

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

Event Date 01/28/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone: (b)(6).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

It was reported that an unknown patient underwent a cardiovascular procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ large.There was thrombus in the valve.The physician detected a thrombus in the valve of the vizigo sheath after withdrawing of the pentaray catheter.The physician tried for approximately 5 minutes to aspirate the thrombus but it was not possible.With a bigger syringe, the physician was able to manage aspiration.This sheath was replaced with another of the same type, so that procedure was ended successfully.No patient consequences were reported.The activated clotting time (act) was 200 and the sheath with the pentaray catheter were only in the right ventricle.The sheath was flushed before he introduced it and when the catheter was withdrawn.The pentaray was flushed constantly with 2ml/min.There was a 10 minute delay, the procedure was successfully completed with not patient consequences.Thrombus/clot is mdr-reportable.

Manufacturer Narrative

On 18-feb-2022, bwi received additional information regarding the event.The thrombus was located in the valve of the sheath.The system did not present any error messages and the physician/user did not see any product problems.There were no issues related to temperature and flow on the catheter.The generator parameters and thresholds were set to power control mode, temp cut-off 40 degree.The thrombus was detected before the ablation starts.The patient was treated with apixaban but he paused it the morning of the procedure.Act practice: the act should be over 300 and they checked it after the transseptal puncture (tsp) every 15 min.When they have seen the thrombus they were still in the right side of the heart.They checked the act after they have seen the thrombus in the valve of the sheath and the act was 200.The patient got 5,000 units of heparin before the tsp and 5,000 units after the tsp ¿ so the patient got 10.000 in total of heparin units.The generator used in the procedure was a stockert gmbh, smartablate generator and pump information stockert gmbh, smartablate pump.The patient has not exhibited any neurological symptoms since the procedure was completed.The physician said it was a small thrombus so he didn¿t expect any problems.The physician said that at the right side of the heart it isn¿t a risk but at the left side potentially yes is a risk.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

On 12-apr-2022, the product investigation was completed based on received photos of the complaint device.Device investigation details: the photos provided by the customer showed a syringe with foreign material.It can be concluded that it was thrombus.A device history record evaluation was performed for the finished device [(b)(4)] number, and no internal actions related to the reported complaint condition were identified.The issue reported by the customer was confirmed based on the pictures received.The device has not been returned for analysis and is not possible to assign a root cause based on the current evidence.If the device is received in the future, the product investigation will be performed and updated accordingly.The ifu (instructions for use) contains the following precaution: "use best practices for irrigation to minimize the potential for thrombus formation".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

On 3-jun-2022, the bwi product analysis lab received the device for evaluation.The 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 reference number: (b)(4).

Manufacturer Narrative

On 24-jul-2022, the product investigation was completed.It was reported that an unknown patient underwent a cardiovascular procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ large.There was thrombus in the valve.Device evaluation details: visual analysis of the returned sample revealed that no damage or anomalies were observed.Then, the distal sheath end was closed off with an adapter, the proximal end was connected to the pressure gage and a syringe was connected to the gage.After that, negative pressure was applied there were no air leaks or bubbles.Then, the test was repeated with positive pressure and no air leak or bubbles were detected.A device history record evaluation was performed on finished device number 00001803, and no internal actions related to the reported complaint condition were identified.No issues were observed during the testing of the device, however, it was confirmed since it was observed on the photos provided by the customer.There may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: : (b)(4).

• Brand Name: CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ LARGE
• 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: 13520116
• MDR Text Key: 289007001
• Report Number: 2029046-2022-00286
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835016260
• UDI-Public: 10846835016260
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K170997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2022
• Device Model Number: D138503
• Device Catalogue Number: D138503
• Device Lot Number: 00001803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2021
• 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: PENTARAY CATHETER.; PENTARAY CATHETER.; SMARTABLATE GENERATOR.; SMARTABLATE PUMP.; UNSPECIFIED TRANSSEPTAL NEEDLE.