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

Model Number D138501

Device Problems Entrapment of Device (1212); Patient Device Interaction Problem (4001)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 06/09/2021

Event Type  Injury  

Manufacturer Narrative

Initial reporter phone: (b)(4).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 a patient underwent a cardiac ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ small and a medical device entrapment (excessive manipulation required) occurred and the patient suffered a rapid drop in blood pressure.After about three hours since the vizigo sheath was put in, when the procedure was completed, an attempt was made to get the vizigo sheath out of the body; however, it seemed that the surface of the vizigo was stuck inside the patient¿s body.The patient complained of pain and the blood pressure dropped rapidly due to nerve reflex.It was pushed up again with a dilator, angiogram confirmed that there was no vascular injury, and it was pulled out again.The patient's blood pressure returned to normal, the patient was fully conscious, and the treatment was successfully completed.Blood pressure decreased due to pain.There was no problem with the chest wall echo.In the opinion of the physician, there was no problem when the patient left the hospital.The physician commented that in the second ablation, since the patient might have undergone catheterization other than ablation, the puncture site was quite hard and resistant from the time of insertion.The vizigo sheath seemed to be stuck inside and on the surface of the blood vessel, not on the skin, in the sensation at hand.Most likely, the nerve reflex was caused by the internal tissues and the ¿sticking pain¿, and the blood pressure temporarily decreased.

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).Per an internal review on (b)(6) 2021, it was noted that additional testing is needed to include dimensional analysis of the outer diameter (od) of the sheath, as well as to ensure that there are no exposed or damaged portions.Additional testing was completed on 21-sep-2021.An outer diameter (od) test was performed and it passed the od test of the sheath and the tip.The specification states that it has to be less than 0.165" according to the device assembly.The od margin measurements are in inches.Sheath diameter- 0.153"; tip diameter- 0.148".Visual test was also performed, and no damages were found on the tip or rings of the vizigo sheath.

Manufacturer Narrative

Additional information was received on 19-aug-2021 and it was reported that the patient fully recovered.There is no further information regarding whether the patient required extended hospitalization; however, since the patient fully recovered during the procedure, it is unlikely that the patient had prolonged hospitalization.The patient is a 60-year-old male.Therefore, a3.Gender, a2.Patient age at the time of event, and a2.Age unit were updated.The device evaluation was completed on 14-sep-2021.It was reported that a patient underwent a cardiac ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ small and a medical device entrapment (excessive manipulation required) occurred and the patient suffered a rapid drop in blood pressure.After about three hours since the vizigo sheath was put in, when the procedure was completed, an attempt was made to get the vizigo sheath out of the body; however, it seemed that the surface of the vizigo was stuck inside the patient¿s body.The patient complained of pain and the blood pressure dropped rapidly due to nerve reflex.It was pushed up again with a dilator, angiogram confirmed that there was no vascular injury, and it was pulled out again.The patient's blood pressure returned to normal, the patient was fully conscious, and the treatment was successfully completed.Blood pressure decreased due to pain.There was no problem with the chest wall echo.In the opinion of the physician, there was no problem when the patient left the hospital.Device evaluation details: visual analysis of the returned sample revealed that no damage or anomalies were observed on the vizigo sheath.Per the event, magnetic, electrical, deflection, flow and pressure were tested.No malfunctions were observed during the product analysis.A device history record was performed for the finished device 00001575 number, and no internal action related to the complaint was found during the review.The root cause of the adverse event remains unknown.The instruction for use states that careful manipulation must be performed in order to minimize the risk of air embolism provide a continuous infusion of heparinized saline solution once the sheath is inserted into the patient.Prior to inserting the device into the patient, pre-assemble the steerable sheath and dilator.Use fluoroscopy and/or intracardiac ultrasound to monitor the advancement of the catheter and removal of the catheter from the sheath.Move the catheter carefully to avoid cardiac damage, perforation, or tamponade.If resistance is encountered, do not use excessive force to advance or withdraw the catheter through the sheath.Follow the manufacturer¿s recommended instructions for use for any device used with the carto vizigo¿ 8.5f bi-directional guiding sheath.During insertion, use caution not to create excessive bends that may lead to crimps in this device.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

The biosense webster, inc.Product analysis lab received the device on 21-jul-2021 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).

• Brand Name: CARTO VIZIGO 8.5F BI-DIRECTIONAL GUIDING SHEATH SMALL
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• MDR Report Key: 12133197
• MDR Text Key: 273557622
• Report Number: 2029046-2021-01070
• 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: foreign
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/23/2022
• Device Model Number: D138501
• Device Catalogue Number: D138501
• Device Lot Number: 00001575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2021
• Initial Date Manufacturer Received: 06/09/2021
• Initial Date FDA Received: 07/08/2021
• Supplement Dates Manufacturer Received: 07/21/2021; 08/19/2021; 09/15/2021
• Supplement Dates FDA Received: 08/16/2021; 09/15/2021; 09/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR