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); Failure to Advance (2524); Device-Device Incompatibility (2919)

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

Event Date 01/10/2022

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 reference number: (b)(4).

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 ¿ small and the introducer got stuck in the sheath.When the physician tried to introduce the ablation catheter through the sheath, he was met with resistance.The physician removed the catheter and sheath and noticed that the introducer was stuck in the sheath, causing an obstruction that made it unusable.The sheath was replaced, and the procedure was completed.No adverse patient consequence was reported.Additional information was received on 11-jan-2022.The resistance they were having with the sheath occurred when they were trying to withdraw it from the sheath.The introducer got stuck.There was an occlusion when irrigating the sheath.The sheath was also reported as partially blocked.The dilator was not able to be moved through the sheath.The introducer stuck/slipped within the sheath was assessed as a mdr reportable malfunction.If the introducer dilator comes out the sheath, patient will require percutaneous or surgical removal.The resistance with sheath and obstructed sheath were assessed as not mdr reportable.

Manufacturer Narrative

Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation (mre) was performed for the finished device (b)(4) number, and no internal action related to the complaint was found during the review.Based on the mre, the h 4.Device manufacture date has been updated.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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: 13443912
• MDR Text Key: 288186432
• Report Number: 2029046-2022-00213
• 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,Followup
• Report Date: 04/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/10/2022
• Device Model Number: D138501
• Device Catalogue Number: D138501
• Device Lot Number: 00001844
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/11/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/10/2021
• 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: UNKNOWN BRAND SHEATH.