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

Model Number D138502

Device Problems Entrapment of Device (1212); Material Deformation (2976); Patient Device Interaction Problem (4001)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/05/2022

Event Type  Injury  

Event Description

It was reported that an unknown patient underwent an atrial fibrillation (afib) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath - medium.The patient required a sub-cutaneous cut down due to sheath getting stuck at the insertion site.It was reported that at the end of the procedure when removing the vizigo sheath.The sheath got stuck in the insertion site.A sub-cutaneous cut down was performed and it was observed that the electrodes on the shaft of the sheath had migrated to the tip of the catheter.The electrodes were pulled back and the sheath was removed successfully with all of the sheath components.The patient remained stable throughout the procedure.The adverse event was discovered during use of biosense webster products, while withdrawing the sheath from the groin.The physician¿s opinion on the cause of this adverse is that was patient tissue abnormalities.A cutdown to free the sheath was intervention provided.The patient outcome of the adverse event was fully recovered.The patient required overnight observation and was discharged the next day.Generator information not relevant.Electrode damaged without foreign material & sharp/rough edges is not mdr-reportable.Medical device entrapment with excessive manipulation required is mdr-reportable.Additionally, since the event is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure and it may require medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr-reportable.

Manufacturer Narrative

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 30-may-2022, the product investigation for the photo was completed.According to the photo/video provided by the customer, there is a electrode detachment issue observed on the picture provided by the customer.A device history record review was performed for the finished device 00001933 number, and no internal actions related to the complaint were found during the review.Furthermore, on 1-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 26-aug-2022, the product investigation was completed.It was reported that an unknown patient underwent an atrial fibrillation (afib) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath - medium.The patient required a sub-cutaneous cut down due to sheath getting stuck at the insertion site.Device evaluation details: visual analysis of the returned sample revealed that electrodes #2, #3, and #4 were detached.The device was visually inspected under magnification, and images of the distal portion of the sheath and the detached electrodes were taken.The root cause of the electrode's detachment could be related to the sheath getting stuck.No issues on the catheter were found that could contribute to the adverse event.The root cause of the stuck issue cannot be determined.A device history record review was performed for the finished device 00001933 number, and no internal actions related to the complaint were found during the review.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 - 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: 14518635
• MDR Text Key: 293278507
• Report Number: 2029046-2022-01103
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/12/2022

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: 03/03/2023
• Device Model Number: D138502
• Device Catalogue Number: D138502
• Device Lot Number: 00001933
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/05/2022
• Initial Date FDA Received: 05/26/2022
• Supplement Dates Manufacturer Received: 05/30/2022; 08/26/2022
• Supplement Dates FDA Received: 06/20/2022; 09/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2022
• 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
• Patient Outcome(s): Required Intervention; Life Threatening