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

Model Number D138502

Device Problem Material Separation (1562)

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

Event Date 11/30/2020

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 ref.#: (b)(4).

Event Description

A patient underwent a cavotricuspid isthmus (cti) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium and a hemostatic valve separation occurred.It was reported that during the ablation procedure, the scrub nurse experienced resistance while introducing the dilator through it.It was then noticed the hemostatic valve became displaced into the transparent hub.The gasket remained in one piece; it did not detach from the sheath.The product was replaced, and the issue resolved.The procedure could be completed without delay.No patient consequences occurred.

Manufacturer Narrative

A patient underwent a cavotricuspid isthmus (cti) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium and a hemostatic valve separation occurred.Device evaluation details: on 1/14/2021, the bwi product analysis lab received the complaint device for evaluation.A visual inspection was performed and it was found that the hemostatic valve is dislodged inside the hub of the device.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 since stress marks and physical damage on the outer diameter were observed under microscope which suggest that excessive force was applied.These findings were reviewed and determined they continue to be deemed mdr reportable.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 was performed and no internal actions related to the reported complaint were identified.The customer complaint was confirmed.The root cause of the dislodged hemostatic valve inside the hub could be related to handling of the device 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.Due to the conditions observed in the hemostatic valve, an internal corrective action has been opened to address this issue.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (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: 11074371
• MDR Text Key: 250324908
• Report Number: 2029046-2020-01983
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/15/2021
• Device Model Number: D138502
• Device Catalogue Number: D138502
• Device Lot Number: 00001252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2021
• Date Manufacturer Received: 01/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1