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

Catalog Number D138502

Device Problems Break (1069); Delivered as Unsterile Product (1421); Tear, Rip or Hole in Device Packaging (2385)

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

Event Date 01/17/2024

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium and a webster ® cs catheter with ez steer® thechnology and auto id.The technician observed that the stop cock on the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium was broken.It appeared that the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium box and packaging pouch seal were both punctured.The caller then reported that the sterility of the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium vizigo was compromised.The carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium was replaced and the issue was resolved.The procedure continued.The caller also reported that because the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium sterility was compromised in the field, the sterility of the webster ® cs catheter with ez steer® thechnology and auto id was also compromised.The webster ® cs catheter with ez steer® thechnology and auto id was replaced and the issue resolved.The procedure continued.Additional information was received.The carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium side port was broken / cracked.The carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium was never advanced into the patient.The carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium reported issues of the stop cock (side port) broken/cracked, packaging pouch seal punctured, and sterility compromised issues were assessed as mdr reportable issues.The webster ® cs catheter with ez steer® thechnology and auto id reported issue of the sterility compromised was assessed as a mdr reportable issue.

Manufacturer Narrative

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 (b)(4) has two reports: (1) mfr # 2029046-2024-00442 for product code d138502 (carto vizigo¿ 8.5f bi-directional guiding sheath - medium).(2) mfr # 2029046-2024-00443 for product code bd710df282ct (webster ® cs catheter with ez steer® thechnology and auto id).

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 20-feb-2024.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.The technician observed that the stop cock on the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium was broken.It appeared that the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium box and packaging pouch seal were both punctured.The caller then reported that the sterility of the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium vizigo was compromised.The carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium was replaced and the issue was resolved.The procedure continued.The device evaluation was completed on 05-mar-2024.The device was returned to biosense webster (bwi) for evaluation.A visual inspection evaluation of the returned device was performed following bwi procedures.Visual analysis of the returned sample revealed that the stopcock was found broken.The packaging and pouch of the device were not returned, for this reason, further analysis could not be performed.A device history record was performed for the finished device batch number, and no internal actions were identified.The side port broken issue was confirmed; however, since no packaging was returned, the sterilization compromise and open pouch issues reported could not be confirmed.The root cause of the damage in the device could be related to the condition observed with the package reported by the customer.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi¿s quality system.Explanation of codes: investigation findings: no findings available (c20) / investigation conclusions: appropriate term/code not available (d17) / component code: appropriate term/code not available (g07002) were selected as related to the customer¿s reported ¿box and packaging pouch seal were both punctured¿ and ¿sterility compromised¿ issues.In addition, biosense webster inc.Analysis finding of the ¿the packaging and pouch of the device were not returned, for this reason, further analysis could not be performed¿.Investigation findings: fracture problem (c070603) / investigation conclusions: cause not established (d15) / component code: stopcock (g04123) were selected as related to the customer¿s reported ¿stop cock broken¿.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: 18677391
• MDR Text Key: 336080603
• Report Number: 2029046-2024-00442
• Device Sequence Number: 1
• Product Code: DYB
• 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
• Report Date: 03/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D138502
• Device Lot Number: 60000248
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2023
• 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: BI DIR 7FR DEF CS,D-F,12 PIN