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

Model Number D138502

Device Problem Delivered as Unsterile Product (1421)

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

Event Date 10/13/2022

Event Type  malfunction  

Manufacturer Narrative

The product has not returned for analysis, however, a picture was provided by the customer.Evaluation is still in progress.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.Biosense webster manufacturer's reference number pc-(b)(4) has three complaints that are related to the same incident.Manufacturer's reference number: pc-(b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with three carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium's and had sterilization compromised issues.It was reported when opening a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium for the procedure, moisture was observed in the tubing.All of the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium were then examined.Two other sheaths had active moisture inside the sterile packaging.It was noticed that the impacted products were all from the same lot.The bwi representative requested that the sheaths that were still inside the sterile packaging be sent back unopened so the complaint can fully be investigated.Additional information was received.There was no damage to the outer box or packaging.Device was secured properly to the tray.No damage seen.The three carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium's were assessed as mdr reportable for sterilization compromised issues.

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation 18-nov-2022.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

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium's and had sterilization compromised issues.The investigation was completed on 27-feb-2023.A picture was received for evaluation following biosense webster's procedures.According to the picture provided by the customer, the catheter was observed inside the pouch with drops of an oily substance at the hub/side port section.The customer complaint was confirmed based on the picture received.The product analysis was performed as appropriate in order to find a root cause of the complaint.The product was returned to biosense webster (bwi) for evaluation.Visual inspection of the returned device was performed following bwi procedures.Visual analysis revealed an oily substance inside the package and on the irrigation tube of the device.Fourier transform infrared spectroscopy [ftir] analysis was performed, and the infrared (ir) data reveals that the unknown material is principally composed of timethoxy (3,3,3-trifluoropropyl) silane-base material.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 due to the quantity applied; since it was found where the hemostatic valve is placed inside the packaging.A supplier internal corrective action has been opened to investigate this issue.The issue reported by the customer was confirmed.This product issue will be addressed through bwi¿s quality system.The supplier internal corrective action is being followed to reduce these issues.A device history record was performed for the finished device batch number, and no internal actions were identified.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.Explanation of codes: -investigation findings: appropriate term/code not available (c22) and inappropriate material (c0602)/ investigation conclusions: cause not established (d15) were selected as related to the picture provided, customer¿s reported ¿sterilization compromised¿ issue and the biosense webster inc.Analysis finding of the ¿other foreign material¿ issue¿.-investigation findings: inappropriate material (c0602)/ investigation conclusions: cause traced to manufacturing (d03) / component code: device ingredient or reagent (g01003) were selected as related to the customer¿s reported ¿sterilization compromised¿ issue and the biosense webster inc.Analysis finding of the ¿other foreign material¿ issue¿.-investigation findings: manufacturing process problem identified (c16)/ investigation conclusions: cause traced to manufacturing (d03) / component code: appropriate term/code not available (g07002) were selected as related to the customer¿s reported ¿sterilization compromised¿ issue and the biosense webster inc.Analysis finding of the ¿manufacturing process related¿ issue.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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 15764126
• MDR Text Key: 307208210
• Report Number: 2029046-2022-02747
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/20/2023
• Device Model Number: D138502
• Device Catalogue Number: D138502
• Device Lot Number: 00002064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2022
• 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: 8.5F SHEATH WITH CURVE VIZ MDC.; 8.5F SHEATH WITH CURVE VIZ MDC.