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

Model Number D138503

Device Problems Material Separation (1562); Detachment of Device or Device Component (2907)

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

Event Date 12/09/2020

Event Type  malfunction  

Manufacturer Narrative

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 reference number: (b)(4).

Event Description

It was reported that a patient underwent cardiac ablation procedure for left non-ischemic ventricular tachycardia with a carto vizigo¿ 8.5f bi-directional guiding sheath - large where hemostatic valve detachment occurred.It was reported that the hemostatic valve and the brim cap detached from the carto vizigo¿ 8.5f bi-directional guiding sheath - large detached when the healthcare professional was flushing the sheath.The sheath was not introduced into the patient's body.No air entered the patient, and no patient consequences were reported.The sheath was replaced and the procedure was continued.It was also reported that the carto 3 system was cycling 1-2-3 through the initialization phase.To troubleshoot the carto 3 system was rebooted several times.Around the 3rd time of the reboot, the carto 3 system displayed "location pad current leak".The caller turned off the patient interface unit and exchanged the location pad extension cable.The patient interface unit was rebooted, and the initialization was completed.' the location pad issue is not mdr-reportable.The start-up error is not mdr-reportable.The hemostatic valve detachment is mdr-reportable.

Manufacturer Narrative

On (b)(6) 2021, the bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.It was reported that a patient underwent cardiac ablation procedure for left non-ischemic ventricular tachycardia with a carto vizigo¿ 8.5f bi-directional guiding sheath - large where hemostatic valve detachment occurred.It was reported that the hemostatic valve and the brim cap detached from the carto vizigo¿ 8.5f bi-directional guiding sheath - large detached when the healthcare professional was flushing the sheath.The sheath was not introduced into the patient's body.No air entered the patient, and no patient consequences were reported.The sheath was replaced and the procedure was continued.It was also reported that the carto 3 system was cycling 1-2-3 through the initialization phase.To troubleshoot the carto 3 system was rebooted several times.Around the 3rd time of the reboot, the carto 3 system displayed "location pad current leak".The caller turned off the patient interface unit and exchanged the location pad extension cable.The patient interface unit was rebooted, and the initialization was completed.' the location pad issue is not mdr-reportable.The start-up error is not mdr-reportable.The hemostatic valve detachment is mdr-reportable.Device evaluation details: according to pictures provided by customer, brim cap and hemostatic valve appears detached from the hub.The physical device was also inspected.A brim cap, hemostatic valve and friction ring were found detached from hub.Small traces of glue residues were found on brim cap and this is evidence that the device was properly manufactured.No stress marks observed on hemostatic valve.A device history record evaluation was performed for the finished device 00001085 number, and no internal action related to the complaint was found during the review.Customer complaint was confirmed.The root cause of the brim cap and hemostatic valve detachment could be related to handling of the device during the procedure however, this cannot be conclusively determined.An internal corrective action has been opened to investigate the conditions observed in the hemostatic valve.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; 33 technology drive; irvine CA 92618
• MDR Report Key: 11101668
• MDR Text Key: 229527153
• Report Number: 2029046-2020-02039
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835016260
• UDI-Public: 10846835016260
• Combination Product (y/n): N
• PMA/PMN Number: K170997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/23/2021
• Device Model Number: D138503
• Device Catalogue Number: D138503
• Device Lot Number: 00001085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2021
• Date Manufacturer Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM