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

Model Number D138502

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/27/2020

Event Type  malfunction  

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).

Event Description

It was reported that during a cardiac ablation procedure for paroxysmal atrial fibrillation, when the catheter was inserted within the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium into the vein, a leak of blood (few drops) through the sheath at the level of the hemostatic valve was observed.The sheath was replaced, and the issue resolved.Patient¿s hemodynamics was not compromised.No medical/surgical intervention was required to stop the bleeding.No air entered to the patient¿s body.Since there is no indication of hemodynamics disruption or required intervention, this patient event is not mdr reportable.The complaint is mdr reportable as the hemostatic valve was compromised.

Manufacturer Narrative

On 10/1/2020, the bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.Sheath was inspected, and visual analysis revealed that hemostatic valve appeared dislodged inside of hub.Brim cap and friction ring remain intact.It was determined that the issue observed could be related to the incorrect insertion of the dilator into the sheath causing the dislodgment.A device history record (dhr) was performed, and no internal action related to the complaint was found during the review.Customer complaint was confirmed.The root cause of the damage on the hemostatic valve inside the hub could be related with the excessive force and handling of the sheath during the procedure; however, this cannot be conclusively determined.The odp (optimal device performance guide) provide additional instructions on how to insert the dilator into the sheath.In addition, there is evidence that the sheath 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: 10576843
• MDR Text Key: 209990622
• Report Number: 2029046-2020-01307
• Device Sequence Number: 1
• Product Code: LYB
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2021
• Device Model Number: D138502
• Device Catalogue Number: D138502
• Device Lot Number: 00001336
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2020
• Date Manufacturer Received: 10/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1