MAUDE Adverse Event Report: STERILMED, INC.; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY, REPROCESSED

Catalog Number	RD128208
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to sterilmed for further evaluation.A non-sterile reprocessed reprocessed pentaray nav eco high density mapping catheter, f curve, 7f, 115cm was received contained in the decontamination bag.Upon receipt of the device, a visual inspection was performed, and the two spines were damaged with cable exposed.The physical mark on the device indicated that it had been reprocessed one (1) time.The catheter couldn't connect.It couldn¿t connect to the carto 3 system.A device history record (dhr) was performed, and no internal actions were identified.The issue reported event regarding the magnetic sensor error being displayed cannot be evaluated through functional test, since the damage noticed on the spines prevent the ability to connect the device.With the limited information available, the root cause of the damages found on the device remains unknown.There is no indication that the issue encountered is a result of a defect inherently related to the manufacture of the device.The damage on the spines was not originally reported, and the exact time of occurrence cannot be determined; 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% electrical testing during reprocessing to prevent sensor issues from leaving the facility.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 pentaray nav eco high density mapping catheter and the carto displayed error 116 (magnetic sensor error) for the catheter.The catheter cable was replaced, and the issue did not resolve.The catheter was replaced and the issue resolved.This event was originally assessed as not mdr reportable.The device was returned for analysis, and two spines were damaged with cable exposed.This finding is mdr reportable.

• Brand Name: NA
• Common Device Name: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY, 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: 22119489
• Report Number: 2134070-2025-00008
• Device Sequence Number: 15219590
• Product Code: NLG
• UDI-Device Identifier: 10888551045179
• UDI-Public: (01)10888551045179(17)270108(10)2183909
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K201806
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• 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 Catalogue Number: RD128208
• Device Lot Number: 2183909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 05/30/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CARTO 3 SYSTEM; NGEN GENERATOR
• Patient Sex: Unknown