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

Model Number D138502

Device Problems Material Perforation (2205); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/31/2020

Event Type  malfunction  

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation.No visual damage or anomalies observed.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 ref.No: (b)(4).

Event Description

It was reported that a patient underwent a ischemic ventricular tachycardia (isvt) procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium.It was reported that the carto vizigo¿ 8.5f bi-directional guiding sheath - medium was not pointing in the correct way.The sheaths dilator went through the side hole instead of the end of the sheath.Thus, they never had the opportunity to visualize, as the sheath was withdrawn from the body before and catheter was inserted or sheath hook up.The sheath was replaced and the issue was resolved.There was no patient consequence.This event was assessed as not mdr reportable.During further review on may 29, 2020, this issue has been re-assessed as mdr reportable as it has been assessed that there is a possibility that the guidewire may be misaligned and thus presented an opportunity for perforation.The awareness date was reset to may 29, 2020.

Manufacturer Narrative

Initially it was assessed as mdr reportable for the carto vizigo¿ 8.5f bi-directional guiding sheath - medium not pointing in the correct way.The sheaths dilator went through the side hole instead of the end of the sheath.However, during additional assessment, it was determined on (b)(6) 2020 that the most probable outcome of this failure mode is a procedure delay.Therefore, there was no risk to the patient.This event was reassessed from mdr reportable to not mdr reportable.The complaint remains reportable for the biosense webster, inc.Product analysis lab finding of the hemostatic valve dislodgement.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 observed on july 17, 2020 that the hemostatic valve was dislodged inside the hub and an irrigation hole was found damaged.The friction ring and brim cap remained intact.Initially it was reported that the sheaths dilator went through the side hole instead of the end of the sheath.Therefore, the returned condition of the irrigation hole damage remains assessed as a mdr reportable issue.The additional observation of the hemostatic valve dislodgement was assessed as a mdr reportable issue.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 device evaluation was completed on (b)(6) 2020.It was reported that a patient underwent a ischemic ventricular tachycardia (isvt) procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium.It was reported that the carto vizigo¿ 8.5f bi-directional guiding sheath - medium was not pointing in the correct way.The sheaths dilator went through the side hole instead of the end of the sheath.Thus, they never had the opportunity to visualize, as the sheath was withdrawn from the body before and catheter was inserted or sheath hook up.The sheath was replaced and the issue was resolved.There was no patient consequence.The device was visually inspected, the hemostatic valve was found dislodged into the hub and an irrigation hole on tip was found damaged.It was determined that the issue observed could be related to the incorrect insertion of the dilator into the sheath causing the dislodgment of the valve and leaking blood since stress marks and physical damage on the outer diameter were observed under microscope which suggest that excessive force was applied.According to the odp (optimal performance guide), there are some precautions on inserting the dilator into the vizigo sheath.Always insert a dilator straight into the center of the sheath¿s valve to prevent damage to the valve.Do not insert a dilator at an angle, as damage to the sheath valve may occur.A device history record evaluation was performed for the finished device, and no internal action related to the complaint was found during the review.The issue reported by the customer was confirmed.It appears to be related to the incorrect introduction of the vessel dilator.The odp (optimal device performance guide) provides additional instructions on how to insert the dilator into the sheath.In addition, there is evidence that the device was manufactured in accordance with documented specification and procedures.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; 33 technology drive; irvine CA 92618
• MDR Report Key: 10190503
• MDR Text Key: 196418263
• Report Number: 2029046-2020-00751
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835016277
• UDI-Public: 10846835016277
• 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,Followup
• Report Date: 03/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/08/2020
• Device Model Number: D138502
• Device Catalogue Number: D138502
• Device Lot Number: 00001235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2020
• Initial Date Manufacturer Received: 05/29/2020
• Initial Date FDA Received: 06/24/2020
• Supplement Dates Manufacturer Received: 07/17/2020; 08/14/2020; 12/04/2020
• Supplement Dates FDA Received: 08/13/2020; 09/02/2020; 12/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN BRAND CATHETER; UNKNOWN BRAND SHEATH