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

Catalog Number	CREFP6
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	08/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation ablation and the patient experienced allergic skin reaction from the carto® 3 system external reference patches.The allergic skin reaction required medication.Patient had an allergic reaction to all of the patches (ecg reference patches, indifferent electrode, and carto 3 system reference patches).The rash was discovered post procedure.The patient was given hydrocortisone and benadryl.The procedure was completed successfully.The patient was stable.
Additional Manufacturer Narrative
D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.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
Per internal review on 18-sep-2024, it was identified that the manufacturing site address was mistakenly documented on the wrong line.(g1.Manufacturer site addr.Street line 2) the address has now been populated on g1 manufacturer site addr.Street line 1).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
On 25-sep-2024, bwi received additional information regarding the event.The physician's opinion on the cause of the adverse event was an allergic reaction due to chemicals used to adhere the product to the skin.The patient is suspected to make a full recovery.Furthermore, the product investigation was completed as the complaint device had been discarded.Device investigation details: an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.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; 814 airport way; sandpoint
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 20251301
• Report Number: 2029046-2024-03143
• Device Sequence Number: 8163690
• Product Code: DQK
• UDI-Device Identifier: 20846835000129
• UDI-Public: 20846835000129
• Combination Product (Y/N): N
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: CREFP6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2024
• Supplement Date Received by Manufacturer: 09/18/2024; 09/26/2024
• Initial Report FDA Received Date: 09/18/2024
• Supplement Report FDA Received Date: 09/18/2024; 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: CARTO 3 SYSTEM.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown