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

Model Number D138502

Device Problem Device-Device Incompatibility (2919)

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

Event Date 05/02/2022

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium for which biosense webster¿s product analysis lab (pal) identified a hemostatic valve separation issue.It was initially reported by the customer that while prepping the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium there was resistance when trying to advance the dilator into the sheath, and the dilator would not advance.The carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium was replaced and the issue resolved.The procedure continued.There was no patient consequence.The customer¿s reported issue of resistance with the sheath is not considered to be an mdr reportable issue since an increased potential for patient injury is remote.On (b)(6) 2022, the bwi pal revealed that a visual inspection of the returned device found the hemostatic valve was dislodged inside the hub of the device.The finding was reviewed and determined to be an mdr reportable malfunction.

Manufacturer Narrative

Device evaluation details: the product was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.Bwi then conducted a visual inspection and microscopic examination of the returned device.Visual analysis of the returned sample revealed that the hemostatic valve was dislodged inside the hub of the device, the shaft, the brim cap and the silicone ring were in the correct position and found in good conditions.The experienced resistance could have been related to the hemostatic valve separation.A functional test was performed, in accordance with bwi procedures.The vessel dilator and stsf catheter were introduced into the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium and no resistance was felt during the testing.The outer diameter vessel dilator was measured, and it was within specifications.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.As part of bwi¿s quality process, all devices are manufactured, inspected, and released to approved specifications.A device history record evaluation was performed, and no internal actions related to the reported complaint condition were identified.Additional investigation was initiated to address the root cause for the resistance to sheath issues and for the hemostatic valve dislodgment.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; 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: 15100662
• MDR Text Key: 303853422
• Report Number: 2029046-2022-01706
• 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
• Report Date: 07/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/11/2023
• Device Model Number: D138502
• Device Catalogue Number: D138502
• Device Lot Number: 00001935
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2022
• Date Manufacturer Received: 06/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2022
• 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
• Treatment: 8.5F SHEATH WITH CURVE VIZ MDC