MAUDE Adverse Event Report: BIOSENSE WEBSTER INC REFERENCE PATCH CARTO 3; 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	11/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a cardiac ablation procedure and upon opening, the seal part was torn.The device was not used on the patient.They replaced the reference patch with another one.No adverse patient consequence was reported.
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.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
The biosense webster, inc.Product analysis lab received the device for evaluation.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 a cardiac ablation procedure and upon opening, the seal part was torn.The device was not used on the patient.They replaced the reference patch with another one.No adverse patient consequence was reported.Product investigation details: the device was returned to johnson & johnson medtech (j&j medtech) for evaluation.A visual and electrical inspection of the returned device was performed in accordance with j&j medtech procedures.Visual analysis of the returned device revealed that only one patch was returned, and it was broken around the edges.Stress marks were also observed on this area suggesting that excessive force was applied.The outer packaging was not returned for the investigation.As such, further investigation could not be performed.A device history record was performed for the finished device number lot ll026845, and no internal action related to the complaint was found during the review.The issue reported by the customer could not be confirmed.The potential cause of the damage in the patch could be related to the handling of the device during or after the procedure; however, this could not be conclusively determined.As part of johnson & johnson medtech¿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.H6.Investigation conclusions code of " appropriate term/code not available (d17)" represents the product returned condition as being unable to be analyzed.Manufacturer's reference number: (b)(4).

• Brand Name: REFERENCE PATCH CARTO 3
• 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
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 20898501
• Report Number: 2029046-2024-03954
• Device Sequence Number: 20100909
• Product Code: DQK
• UDI-Device Identifier: 20846835000129
• UDI-Public: (01)20846835000129(17)251126(10)LL026845
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/07/2025

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: 11/26/2025
• Device Catalogue Number: CREFP6
• Device Lot Number: LL026845
• 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: 11/14/2024
• Supplement Date Received by Manufacturer: 01/28/2025; 02/10/2025
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 01/29/2025; 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2024
• 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