MAUDE Adverse Event Report: STERILMED, INC. CATHETER EZ STEER BI-DIRECTIONAL CS DEFECTABLE CURVE TYPE: F-J 12 PIN AUTO ID; CATHETER, RECORDING, ELECTRODE, REPROCESSED

Model Number	BIOBD710FJ282CT
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed and no internal actions related to the complaint was found during the review.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 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 reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) procedure with a catheter ez steer bi-directional cs defectable curve type: f-j 12 pin auto id and an issue occurred of foreign matter inside the packaging.It was reported that the reprocessed catheter (catheter ez steer bi-directional cs defectable curve type: f-j 12 pin auto id) was dirty upon opening the package.It had blood on it when it was opened.The catheter was replaced and that resolved the issue.The procedure continued.There was no patient consequence reported.Additional information was received.The blood was observed near the handle.It was inside the sterile package.It was described as dried blood.There was no patient consequence as it was caught before it was introduced into the sterile field.The event was assessed as mdr reportable for foreign matter inside the packaging.
Additional Manufacturer Narrative
It was reported that a patient underwent an atrial fibrillation (afib) procedure with a catheter ez steer bi-directional cs defectable curve type: f-j 12 pin auto id and an issue occurred of foreign matter inside the packaging.It was reported that the reprocessed catheter (catheter ez steer bi-directional cs defectable curve type: f-j 12 pin auto id) was dirty upon opening the package.It had blood on it when it was opened.The catheter was replaced and that resolved the issue.The procedure continued.There was no patient consequence reported.Additional information was received.The blood was observed near the handle.It was inside the sterile package.It was described as dried blood.There was no patient consequence as it was caught before it was introduced into the sterile field.The device evaluation was completed on 11-apr-2023.The device was returned to sterilmed for further investigation.A non-sterile reprocessed ez steer bi-directional cs catheter was received contained in the decontamination bag.Upon receipt of the catheter, visual inspection was performed, and it revealed that the catheter was returned with no apparent damage.The tag id attached to the catheter indicated that it had been reprocessed one (1) time.The issue documented that the catheter had blood residues near the handle could not be confirmed since the product was received without any foreign matter.No additional evidence was provided showing the alleged issue.A review of manufacturing documentation associated with the lot 2182815 revealed that there were no internal actions related to device manufacture or inspection.As part of sterilmed¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Devices undergo 100% visual inspection to detect the presence of contaminants during the reprocessing cycle.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
The sterilmed product analysis lab received the device for evaluation on 04-apr-2023.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).

• Brand Name: CATHETER EZ STEER BI-DIRECTIONAL CS DEFECTABLE CURVE TYPE: F-J 12 PIN AUTO ID
• 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 55446
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16549968
• Report Number: 2134070-2023-00007
• Device Sequence Number: 20319917
• Product Code: NLH
• UDI-Device Identifier: 10888551005944
• UDI-Public: 10888551005944
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 04/13/2023

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: 12/01/2023
• Device Model Number: BIOBD710FJ282CT
• Device Catalogue Number: BIOBD710FJ282CT
• Device Lot Number: 2182815
• 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: 02/15/2023
• Supplement Date Received by Manufacturer: 04/04/2023; 04/11/2023
• Initial Report FDA Received Date: 03/15/2023
• Supplement Report FDA Received Date: 04/10/2023; 04/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN BRAND CATHETER
• Patient Sex: Unknown