MAUDE Adverse Event Report: STERILMED, INC. CABLE INTERFACE CARTO 3 SYSTEM SPLIT HANDLE; CATHETER, RECORDING, ELECTRODE, REPROCESSED

Catalog Number	BIOD134401
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product analysis lab received the device for evaluation on 20-may-2025.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.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 sterilmed inc., or its employees that the report constitutes an admission that the product, sterilmed 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 ref.No: (b)(4).
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation ablation procedure with a reprocessed cable interface carto 3 system split handle and during pre-op, the handle of the cable was dirty which was seen through the sterile packaging.The substance looks like betadine.The primary plastic packaging was not opened, since the device did not look clean.There was no physical damage to the package observed.There was no patient consequence.
Additional Manufacturer Narrative
It was reported that a patient underwent an atrial fibrillation ablation procedure with a reprocessed cable interface carto 3 system split handle and during pre-op, the handle of the cable was dirty which was seen through the sterile packaging.The substance looks like betadine.The device was returned to sterilmed for further evaluation.A sterile reprocessed cable interface carto 3 system split handle was received, contained inside the sterile pouch.A visual inspection was performed, and in the connector an unknown dried substance was found.The physical mark on the device indicated it had been reprocessed two (2) times.Fourier transform infrared spectroscopy (ft-ir) test was performed.The foreign liquid was extracted from the surface using precision instruments and subjected to infrared spectroscopy without any further preparation.The analysis indicated that the foreign substance primarily exhibits vibrations characteristic of epoxy-based materials.A comparison test was the final step in the ft-ir analysis, showing minor differences between the spectra.However, the predominant epoxy vibrations were confirmed, indicating that the liquid is largely composed of epoxy-based material.The ir spectrum of the liquid revealed an epoxy-based composition, albeit with slight variations.However, the source and cause of these materials' presence in the product are still unknown.A device history record (dhr) was performed, and no internal actions were identified.The customer complaint was confirmed during the device inspection.As a result, an internal action was formally documented to address this issue, and a thorough investigation will be conducted to identify the root cause and implement appropriate corrective actions.This issue is being addressed through sterilmed¿s quality system and actions are being taken on the supplier¿s side.Correction to d1.Brand name to na.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.No: (b)(4).

• Brand Name: CABLE INTERFACE CARTO 3 SYSTEM SPLIT HANDLE
• Common Device Name: CATHETER, RECORDING, ELECTRODE, REPROCESSED
• Manufacturer (Section D): STERILMED, INC.; 5010 cheshire parkway; ste 2; plymouth MN 55446
• Manufacturer (Section G): STERILMED, INC.; 5010 cheshire parkway; ste 2; plymouth MN 55446
• Manufacturer Contact: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 22108387
• Report Number: 2134070-2025-00007
• Device Sequence Number: 8149870
• Product Code: NLH
• UDI-Device Identifier: 10888551006231
• UDI-Public: (01)10888551006231(17)260108(10)2222175
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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

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: 01/08/2026
• Device Catalogue Number: BIOD134401
• Device Lot Number: 2222175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2025
• Supplement Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 05/29/2025
• Supplement Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2025
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown