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

Model Number D138501

Device Problems Obstruction of Flow (2423); Detachment of Device or Device Component (2907)

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

Event Date 12/21/2021

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial flutter right (r-afl) procedure with a carto vizigo¿ 8. 5f bi-directional guiding sheath - small and the biosense webster inc, (bwi) product analysis lab observed that the hemostatic valve was not found on the hub component nor inside the sheath. Initially, it was reported that the dilator of the vizigo¿ sheath could not pass through the sheath. The caller stated that it stopped being able to advance about halfway through the sheath. The sheath was replaced, and the issue was resolved, and the procedure was continued. No adverse patient consequences were reported. The issue of obstructed sheath was assessed as not mdr reportable. There is evidence of a product malfunction, as the device failed to meet its performance specification or otherwise performed as intended. However, the potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote. This event is being reported because the biosense webster inc, (bwi) product analysis lab received the device for evaluation and found that the hemostatic valve was not found on the hub component nor inside the sheath. This was assessed as mdr reportable. Therefore, the awareness date for this reportable lab finding is 09-feb-2022.

Manufacturer Narrative

The product was returned to biosense webster inc. (bwi) for evaluation. Bwi conducted a visual inspection and functional test of the returned device. Visual analysis of the returned sheath revealed that the hemostatic valve was not found on the hub component nor inside the sheath. In addition, some bents were observed on the vessel dilator. A functional test was performed, in accordance with bwi procedures. The vessel dilator and stsf catheter were introduced into the vizigo sheath and some resistance was felt during the testing. The od vessel dilator was measured, and it was within specifications. A device history record evaluation was performed for the finished device number 00001837 and no internal action was found during the review. As part of the quality process, all devices are manufactured, inspected, and released to approved 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. At this time it is not possible to determine the root cause of the hemostatic valve condition, however, based on the information provided, the condition reported has origin in someplace external to the manufacturing environment. Additional investigation was initiated to address the root cause for the resistance to sheath issues. Manufacturer's reference number: (b)(4).

• Brand Name: CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - SMALL
• 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13692038
• Report Number: 2029046-2022-00482
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835016253
• UDI-Public: 10846835016253
• 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: Company Representative

Reporter Occupation

• Type of Report: Initial
• Report Date: 03/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 11/02/2022
• Device Model Number: D138501
• Device Catalogue Number: D138501
• Device Lot Number: 00001837
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2022
• Date Manufacturer Received: 02/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sex: No Answer Provided
• Patient Treatment(s): UNK BRAND SHEATH