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

Model Number D138503

Device Problems Delivered as Unsterile Product (1421); Contamination /Decontamination Problem (2895)

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

Event Date 02/03/2023

Event Type  malfunction  

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 28-feb-2023.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.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent a procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ large and a sterilization compromised issue occurred.When starting preparation of the material and before opening the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ large, tiny drops of liquid which seems like condensed water were noticed inside the sterile package.It was decided to report the issue and replace the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ large before opening it.The event occurred during sterile processing and during field inspection.There was no patient consequence.The event was assessed as mdr reportable for a sterilization compromised issue.

Manufacturer Narrative

It was reported that a patient underwent a procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ large and a sterilization compromised issue occurred.When starting preparation of the material and before opening the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ large, tiny drops of liquid which seems like condensed water were noticed inside the sterile package.It was decided to report the issue and replace the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ large before opening it.The event occurred during sterile processing and during field inspection.There was no patient consequence.The investigation was completed on 21-apr-2023.A picture was received for evaluation following biosense webster's procedures.According to pictures provided by the customer, drops of foreign material were observed inside the pouch of the vizigo sheath.The customer complaint was confirmed based on the picture received.The product analysis was performed as appropriate in order to find the root cause of the complaint.The device was returned to biosense webster (bwi) for evaluation.Visual inspection of the returned device was performed following bwi procedures.Visual analysis revealed foreign material inside the package.A fourier transform infrared spectroscopy (ft-ir) analysis was performed and the infrared (ir) data reveals that unknown liquid exhibited the chemical composition of fluourosilane base material, presumably a trifluoropropylmethylsiloxane.The source of origin remains unknown.Based on the preliminary investigation performed, it was confirmed that the ¿moisture/humidity¿ reported by the customer could be related to the silicon coating applied to the hemostatic valve surface.This silicone coating is accidentally migrating to the film section of the pouch since it was found where the hemostatic valve is placed inside the packaging.An internal corrective action has been opened to reduce these issues.A device history record was performed for the finished device batch number, and no internal actions were identified.The issue reported by the customer was confirmed.This product issue will be addressed through bwi¿s quality system.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Explanation of codes: -investigation findings: appropriate term/code not available (c22) / investigation conclusions: cause not established (d15) were selected as related to the ¿picture¿ provided.-investigation findings: inappropriate material (c0602) and manufacturing process problem identified (c16) / investigation conclusions: cause traced to manufacturing (d03) / component code: device ingredient or reagent (g01003) were selected as related to the customer¿s reported issue of ¿sterilization compromised¿ biosense webster inc.Analysis finding of the ¿foreign material inside the device packaging¿.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

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(6).During an internal review on 31-may-2023, the h6 medical device problem code was corrected from delivered as unsterile product (a020701) to contamination / decontamination problem (a18).In addition, on 01-jun-2023, the product investigation was reopened to clarify/correct the investigation findings which resulted in the following changes/corrections.A picture was received for evaluation following biosense webster's procedures.According to pictures provided by the customer, drops of foreign material was observed inside the pouch of the vizigo sheath.Based on a preliminary investigation performed, it was confirmed that the ¿moisture/humidity¿ reported by the customer could be related to the silicon coating applied to the hemostatic valve surface.This silicone coating is accidentally migrating to the film section of the pouch since it was found where the hemostatic valve is placed inside the packaging.The customer complaint was confirmed based on the picture received.The product analysis was performed as appropriate in order to find the root cause of the complaint.The device was returned to biosense webster (bwi) for evaluation.Visual inspection of the returned device was performed following bwi procedures.Visual analysis revealed foreign material inside the package.A fourier transform infrared spectroscopy (ft-ir) analysis was performed and the infrared (ir) data reveals that unknown liquid exhibited the chemical composition of fluourosilane base material, presumably a trifluoropropylmethylsiloxane.However, based on the preliminary investigation performed, it was confirmed that the ¿moisture/humidity¿ reported by the customer could be related to the silicon coating applied to the hemostatic valve surface.This silicone coating is accidentally migrating to the film section of the pouch since it was found where the hemostatic valve is placed inside the packaging.A device history record was performed for the finished device batch number, and no internal actions were identified.The issue reported by the customer was confirmed.This product issue will be addressed through bwi¿s quality system.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.

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).The product investigation was reopened to correct the h6.Component code on 22-feb-2024 from device ingredient or reagent (g01003) to packaging (g04094).During an internal review, noted a correction to the 3500a follow-up #2 as the device evaluation completion should have included ¿an internal corrective action has been opened to reduce these issues.¿.

• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16475927
• MDR Text Key: 311233434
• Report Number: 2029046-2023-00451
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835016260
• UDI-Public: 10846835016260
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K170997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/13/2023
• Device Model Number: D138503
• Device Catalogue Number: D138503
• Device Lot Number: 00002058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2022
• 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: UNKNOWN BRAND SHEATH