MAUDE Adverse Event Report: STERILMED, INC. DIAGNOSTIC EP CATH; CATHETER, RECORDING, ELECTRODE, REPROCESSED

Catalog Number	BIOBD710FJ282RTS
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a pulmonary vein isolation ablation procedure with a reprocessed ep diagnostic catheter and when the catheter was opened there were some fuzz on part of the catheter.The primary packaging of the product was not opened before the surgery.There was no physical damage, or any other issue observed on the package of the device.There was no patient consequence.
Additional Manufacturer Narrative
The device has not yet been returned for analysis.A manufacturing record evaluation was performed and no internal actions related to the complaint was found during the review.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).
Additional Manufacturer Narrative
The product analysis lab received the device for evaluation on 5-mar-2024.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.Section d9 has been updated.Manufacturer's ref.No: (b)(4).
Additional Manufacturer Narrative
It was reported that a patient underwent a pulmonary vein isolation ablation procedure with a reprocessed ep diagnostic catheter and when the catheter was opened there were some fuzz on part of the catheter.The device was returned to sterilmed for further evaluation.A non-sterile reprocessed catheter was received contained in the decontamination bag.Upon receiving the device, visual inspection was performed, and no appearance of damages was observed.No foreign matter/residues were observed on the catheter.The lot number of the device indicated it had been reprocessed one time.A device history record (dhr) was performed, and no internal actions were identified.The issue reported regarding the fuzz on the catheter was not confirmed as no foreign matter/foreign residues were found on the catheter, and no further investigation can be performed without the original packaging.The instructions for use (ifu) indicates the following: ¿ before use, inspect the packaging.Do not use if open or damaged.Using aseptic technique, remove the catheter from its package and place it in a sterile working area.Inspect the catheter carefully for electrode integrity and overall condition.As part of sterilmed's quality process, all devices are manufactured, inspected, and released to approved specifications.Devices undergo 100% inspection at different points, including cleaning, red inspection, sterilization, and package inspection prior to shipping during the reprocessing process to prevent contaminated devices from leaving the facility.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: DIAGNOSTIC EP CATH
• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 18808923
• Report Number: 2134070-2024-00003
• Device Sequence Number: 17977561
• Product Code: NLH
• UDI-Device Identifier: 10888551005951
• UDI-Public: 10888551005951
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K121158
• 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): 02/29/2024

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: 11/08/2024
• Device Catalogue Number: BIOBD710FJ282RTS
• Device Lot Number: 2200638
• 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: 02/08/2024
• Supplement Date Received by Manufacturer: 03/05/2024; 04/02/2024
• Initial Report FDA Received Date: 02/29/2024
• Supplement Report FDA Received Date: 03/28/2024; 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2023
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown