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

Catalog Number	BIOBD710FJ282CT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product has not been returned for analysis, however, a photo of the event was received in which the distal end of a catheter can be seen.The electrode #1 can be seen separated from the shaft of the catheter and tied to the internal wires.No other damages can be seen.A manufacturing record evaluation was performed, and no non-conformances related to the reported complaint condition were identified.The issue reported regarding the broken tip of the catheter was confirmed.This investigation was performed based only on the photos provided.If the product is received after this investigation, an assessment will be performed as per the conditions of the device returned.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 during an atrial fibrillation procedure with a reprocessed ez steer bi-directional cs catheter, the tip broke while entering the sheath.The catheter did not separate into two or more pieces, however, there was wires/braid exposed.There was no physical damage, or any other issue observed on the package of the device.There was no patient consequence.
Additional Manufacturer Narrative
Multiple attempts have been made to obtain the device.However, the device has not been returned for analysis.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.No: (b)(4) h5 and h8 were omitted on initial report.These fields have been updated.

• 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: 18858050
• Report Number: 2134070-2024-00004
• Device Sequence Number: 16970703
• Product Code: NLH
• UDI-Device Identifier: 10888551005944
• UDI-Public: 10888551005944
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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
• 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: 10/31/2024
• Device Catalogue Number: BIOBD710FJ282CT
• Device Lot Number: 2199229
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2024
• Supplement Date Received by Manufacturer: 04/11/2024
• Initial Report FDA Received Date: 03/07/2024
• Supplement Report FDA Received Date: 04/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2023
• 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