MAUDE Adverse Event Report: BIOSENSE WEBSTER INC CARTO® 3 SYSTEM EXTERNAL REFERENCE PATCHES; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Catalog Number	CREFP6
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.E1.Initial reporter phone: (b)(6).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
Event or Problem Description
It was reported that the sterilization pouch of the carto® 3 system external reference patches were not sealed.It was reported that the hospital staff opened a package of a carto® 3 system external reference patches in preparation for a procedure and found that two bags inside were not sealed on one of the sides.The devices were not used on any patient.A replacement of the same lot was opened, and no problem was observed.The procedure was completed without patient's consequence.
Additional Manufacturer Narrative
It was reported that the sterilization pouch of the carto® 3 system external reference patches were not sealed.It was reported that the hospital staff opened a package of a carto® 3 system external reference patches in preparation for a procedure and found that two bags inside were not sealed on one of the sides.The devices were not used on any patient.A replacement of the same lot was opened, and no problem was observed.The procedure was completed without patient's consequence.Device evaluation details: the devices were returned to biosense webster (bwi) for evaluation on 27-may-2024.Visual inspection of the returned devices was performed following bwi procedures.Visual analysis revealed that one side of the packages was not sealed.The supplier opened an investigation for this issue and shared the following results: production associates performing inspection and boxing are required to complete 100% visual inspection of each pouch seal to ensure the seal is across the entire pouch and no product or contamination is in the seal.In addition, production associates are required to complete an in-process inspection of pouch seals hourly and completes amount of pouch seal inspections throughout the work order.To further mitigate the risk of unsealed pouches, a sealer shelf guard was implemented on our impulse sealers used to seal the pouches in april 2024.D-1283-02-24 carto3 system external reference patches lot ll025946 (manufacture date 2023-09-26) was manufactured prior to the implementation of the sealer shelf guard, however the 100% visual inspection by production associates and in-process inspection by production associates and quality were completed and documented in the device history record (dhr).A device history record was performed for the finished device batch number, and no internal actions were identified.The open pouch seal issue reported by the customer was confirmed.The instruction for use (ifu) of the device contain the following recommendation: inspect the external reference patch to ensure that it is in good physical condition.Care should be taken when opening the packaging to ensure that the sealing mechanism is not damaged.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

• Brand Name: CARTO® 3 SYSTEM EXTERNAL REFERENCE PATCHES
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): LEAD LOK INC; 814 airport way; sandpoint ID 83864
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 19274580
• Report Number: 2029046-2024-01522
• Device Sequence Number: 7649350
• Product Code: DQK
• UDI-Device Identifier: 20846835000129
• UDI-Public: 20846835000129
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K090017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/25/2025
• Device Catalogue Number: CREFP6
• Device Lot Number: LL025946
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2024
• Supplement Date Received by Manufacturer: 05/27/2024
• Initial Report FDA Received Date: 05/08/2024
• Supplement Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown