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

Model Number D138501

Device Problems Material Separation (1562); Obstruction of Flow (2423); Material Twisted/Bent (2981)

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

Event Date 03/29/2022

Event Type  malfunction  

Manufacturer Narrative

Device evaluation details: the product was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.Visual inspection and microscopic examination of the returned device were performed following bwi procedures.Visual analysis revealed that the hemostatic valve was dislodged inside of the hub component.A microscopic examination of the hemostatic valve surface showed stress marks on the outer diameter.The damage observed could be related to the incorrect insertion of the dilator into the sheath causing the dislodgment of the valve; the stress marks and physical damage observed suggest that excessive force or manipulation was applied; however, this could not be conclusively determined.The dilator and a good known lab sample catheter were introduced through the sheath, and no obstruction or resistance was felt.The dilator's outer diameter was measured, and dimensions were found within specifications.Resistance could have been related to the hemostatic valve dislodgment.A device history record was performed for the finished device batch number, and no internal actions were identified.The issue reported by the customer could not be replicated during the product investigation; other issues or circumstances may have occurred during the usage of the device that compromised its performance.Odp (optimal device performance guide) contains the following caution: 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 the quality process, all devices are manufactured, inspected, and released to approved specifications.(b)(4).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 an atrial fibrillation (afib) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ small for which biosense webster¿s product analysis lab (pal) identified a hemostatic valve separation issue.It was initially reported by the customer that the dilator of the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ small could not pass through the sheath.Caller stated it stopped being able to advance about halfway through the sheath.The sheath was replaced, and the issue was resolved.The procedure was continued.There was no patient consequence.Additional information was received indicating the sheath was also described to be bent at the proximal end of the sheath.The bent was noticeable after insertion was attempted, not prior to insertion.No occlusion was observed.Irrigation was normal during the preparation phase.Narrowing, blockage, or partial blockage was not noticed, however, the dilator was able to be moved through the sheath with heavy resistance and also be removed.Part was not broken into pieces.No wires were exposed.No lifted or sharp rings were visualized.Based on the information reported by the customer, the event was assessed as not reportable since the potential that the issue of obstructed sheath and bent shaft could cause or contribute to a death or serious injury, or other significant adverse event, are remote.On 18-may-2022, the bwi pal inspected the device and found the hemostatic valve was found dislodged inside the hub component.This was reviewed and assessed to be an mdr reportable malfunction.

• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14639516
• MDR Text Key: 295815666
• Report Number: 2029046-2022-01235
• 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: Other
• Type of Report: Initial
• Report Date: 06/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/05/2023
• Device Model Number: D138501
• Device Catalogue Number: D138501
• Device Lot Number: 00001888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2022
• Initial Date Manufacturer Received: 05/18/2022
• Initial Date FDA Received: 06/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2022
• 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: THMCL SMTCH SF BID, TC, F-J