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

Model Number D138502

Device Problems Break (1069); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 02/17/2022

Event Type  malfunction  

Manufacturer Narrative

The bwi product analysis lab received a photograph of the complaint device for analysis.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.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 an unknown patient underwent an atrial fibrillation (afib) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium.The side port tubing broke off of the sheath.It was reported that while setting up for the procedure and prepping the vizigo sheath, it was noticed that the hard connection for the side port on the sheath had broken off.They noticed the issue before introducing anything into the vizigo sheath.The medical team was just trying to flush the sheath, and the damage was noticed once they tried to connect the syringe to the hub.The hard connection or rigid plastic where the flexible tubing portion connects to valve port hub broke off.The vizigo sheath was replaced and the issue resolved.The procedure continued.A photograph was received of the complaint device, and it was noted that side port tubing appears broken.The hemostasis valve (gasket) did not break into two or more separate pieces.The hemostatic valve/brim cap/hub did not become detached from the sheath.The sheath was not being used on the patient.The side port tubing breaking off the sheath is mdr-reportable.

Manufacturer Narrative

Per an internal review on 10-mar-2022, it was determined that the reported malfunction can not occur during usage of the device.The event can only occur as an out of box failure due to a shipping issue and/or gross handling.As a result, the medical device problem code for "break" (a0401) no longer applies.The updated code is now "manufacturing, packaging, or shipping problem" (a02).The event no longer qualifies as an mdr-reportable event.No further supplemental reports will be submitted regarding the event.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 ¿ 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13695987
• MDR Text Key: 290469827
• Report Number: 2029046-2022-00488
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/10/2022

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: Health Professional
• Device Expiration Date: 12/02/2022
• Device Model Number: D138502
• Device Catalogue Number: D138502
• Device Lot Number: 00001870
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/10/2022
• Was Device Evaluated by Manufacturer?: No
• 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