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	04/19/2024
Type of Reportable Event	Malfunction
Additional 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.Manufacturer's reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto® 3 system external reference patches.When the reference patch packaging was opened, they noticed that the patches were not completely sealed.When the patch was replaced, the issue resolved.There was no patient consequence reported.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.
Additional Manufacturer Narrative
The bwi product analysis lab received the device for evaluation on 16-may-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).
Additional Manufacturer Narrative
It was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto® 3 system external reference patches.When the reference patch packaging was opened, they noticed that the patches were not completely sealed.When the patch was replaced, the issue resolved.There was no patient consequence reported.The device evaluation was completed on 29-may-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 patches were found in good condition.No anomalies or damage were observed.The package of the device was not returned; therefore, further investigation could not be performed.A device history record was performed for the finished device batch number, and no internal actions were identified.The open pouch seal issue could not be confirmed since the package of the device was not returned.Additionally, for this type of failure mode, a supplier manufacturing investigation was requested, and it was determined that to further mitigate the risk of unsealed pouches, a sealer shelf guard was implemented on our impulse sealers used to seal the pouches.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.H6.Component code of ¿appropriate term/code not available (g07002)¿ and h 6.Investigation conclusions of ¿appropriate term/code not available (d17)¿ represents the package of the device was not returned.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® 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: 19321078
• Report Number: 2029046-2024-01584
• Device Sequence Number: 7648845
• Product Code: DQK
• UDI-Device Identifier: 20846835000129
• UDI-Public: 20846835000129
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 06/25/2024

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: 04/23/2025
• Device Catalogue Number: CREFP6
• Device Lot Number: LL026049
• 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: 04/19/2024
• Supplement Date Received by Manufacturer: 05/16/2024; 05/29/2024
• Initial Report FDA Received Date: 05/15/2024
• Supplement Report FDA Received Date: 05/20/2024; 06/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SOUNDSTAR ECO GE 8F CATHETER.; UNK CATHETER.; UNK ECO CABLE.; UNK_CARTO 3.
• Patient Sex: Unknown