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

Catalog Number	BIOBD710DF282CT
Medical Device Problem Code	Signal Artifact/Noise (1036)
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 and electrophysiology study with a diagnostic ep catheter and the catheter only had two working poles with noise on the other three.The catheter was exchanged, and the issue resolved.There was no reported patient consequence.This event is not reportable.Upon receiving the device for evaluation, visual inspection was performed, and the shaft above the electrode #2 was melted.This finding is reportable.
Additional Manufacturer Narrative
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 the shaft above the electrode #2 was melted.No other damages were noted.The lot number of the device indicated it had been reprocessed four (4) times.Microscopic inspection on the melted condition on the shaft revealed that as a result of this condition, the braided wire and internal wires were broken.The catheter was connected to the carto 3 system, and the device was recognized; however, the device was not visualized, and no noise was displayed.The device history records (dhr) for lot number 2201781 were reviewed and no evidence of deficiencies during the reprocessing was found.The serial number (b)(6) was recorded as not defective during the visual inspection.All defective pieces were properly scrapped and accounted for, and no internal actions were generated.The issue reported regarding the noise on the poles could not be evaluated as the damaged condition of the shaft of the device prevented proper functional testing.The damaged condition was not originally reported, and the exact time of occurrence cannot be determined.It is suggested that this condition could have been the result of the post-operative handling of the device; therefore, this is not considered related to the issue reported.As part of sterilmed's quality process, all devices are manufactured, inspected, and released to approved specifications.Devices undergo 100% inspection at different points during the manufacturing process to prevent damages 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: 19047657
• Report Number: 2134070-2024-00006
• Device Sequence Number: 17952521
• Product Code: NLH
• UDI-Device Identifier: 10888551005920
• UDI-Public: 10888551005920
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: 11/15/2024
• Device Catalogue Number: BIOBD710DF282CT
• Device Lot Number: 2201781
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2023
• 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