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

Model Number D138503

Device Problems Material Separation (1562); Obstruction of Flow (2423)

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

Event Date 10/05/2021

Event Type  malfunction  

Event Description

A patient underwent an atrial fibrillation ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ large for which biosense webster¿s product analysis lab (pal) identified a hemostatic valve separation.It was initially reported by the customer that during an atrial fibrillation case, the physician was attempting to insert the dilator into a large-curve vizigo sheath, but was met with resistance.Unable to enter the dilator into the sheath, the nurse assisting the physician then tried flushing the sheath and was again met with resistance and unable to do so.A new sheath was used in it¿s place.The patient was not harmed, and the case was completed successfully without delay.The customer¿s reported ¿obstruction with the sheath" is not considered to be an mdr reportable malfunction since 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.On 19-dec-2021, pal revealed that a visual inspection of the returned device found the hemostatic valve dislodged inside the hub of the device.This finding is considered to be an mdr reportable malfunction.This event was originally considered non-reportable, however, bwi became aware of a reportable malfunction through product analysis on 19-dec-2021 and reassessed it as mdr reportable.

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 carto vizigo sheath sample revealed that the hemostatic valve was found dislodged inside of the hub.Microscopic examination in the hemostatic valve surface and showed evidence of stress marks on the outer diameter.The brim cap and the silicone ring were placed in the correct position and found in good conditions.A device history record was performed and no internal actions related to the reported complaint were identified.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.However, due to the conditions observed in the hemostatic valve, an internal corrective action has been opened to address this issue 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.¿ 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 ¿ LARGE
• 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: 13227637
• MDR Text Key: 286436673
• Report Number: 2029046-2022-00075
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835016260
• UDI-Public: 10846835016260
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K170997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/21/2022
• Device Model Number: D138503
• Device Catalogue Number: D138503
• Device Lot Number: 00001552
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2021
• Date Manufacturer Received: 12/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2021
• 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 LGC