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); Material Perforation (2205)

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

Event Date 08/25/2021

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 an unknown patient underwent an unknown ablation procedure with (2) carto vizigo" 8.5f bi-directional guiding sheath  medium.A piece of grey plastic was removed.Physician tried to do the transeptal puncture and unfortunately removed some pieces of grey plastic, probably from the dilator.The procedure was delayed 5 minutes due to the reported event.Perforation of dilator is mdr-reportable.This report is for the 2nd of 2 reportable carto vizigo" 8.5f bi-directional guiding sheath  medium.The other complaint device was reported under manufacturer report number 2029046-2021-01596.

Manufacturer Narrative

On (b)(6)-2021, the bwi product analysis lab received the device for evaluation.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).

Manufacturer Narrative

On (b)(6) 2021, bwi received additional information regarding the event.It was confirmed that the pieces were related to the dilator.No perforation or foreign material were identified.Subsequently, the product investigation was completed.Device evaluation details: the product was returned to biosense webster for evaluation.Bwi conducted a visual inspection of the returned product.Visual analysis of the returned sample revealed that no damage and it was observed reddish material on the luer hub in the vizigo sheath.Unit was inspected prior leaving the facility as there are functional tests and inspections at control points based on the process flow diagram of this device per its part number that indicates a proper manufacturing in accordance with documented specifications and procedures.A device history record was performed for the finished device 00001456 number, and no internal actions related to the reported complaint condition were identified.No issues were verified during the analysis.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

Per internal review on 22-nov-2021, it was determined that the previously reported medical device problem code (section h6) for "material perforation" (a0410) is not the most fitting code.It has been determined that the "break" (a0401) code is the most fitting code for this 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: 12494064
• MDR Text Key: 272121423
• Report Number: 2029046-2021-01597
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835016277
• UDI-Public: 10846835016277
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup,Followup,Followup
• Report Date: 12/08/2021

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: 09/16/2021
• Device Model Number: D138502
• Device Catalogue Number: D138502
• Device Lot Number: 00001456
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/02/2021
• Initial Date FDA Received: 09/20/2021
• Supplement Dates Manufacturer Received: 09/22/2021; 10/07/2021; 11/22/2021
• Supplement Dates FDA Received: 10/04/2021; 10/27/2021; 12/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2020
• 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