MAUDE Adverse Event Report: STERILMED, INC. EP DIAGNOSTIC CATHETER LIVEWIRE DECA EXTRA LARGE CURL; CATHETER, RECORDING, ELECTRODE, REPROCESSED

Model Number	DAI401941
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not yet been returned for analysis.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 a premature ventricular contraction procedure with a reprocessed ep diagnostic catheter livewire deca extra large curl and there was a separation where the last electrode connects to the shaft of the catheter with internal components exposed.The package was opened at the time the physician requested the device for used, however, it is unknown if there was any physical damage to the packaging.There was no patient consequence.
Additional Manufacturer Narrative
It was reported that a patient underwent a premature ventricular contraction procedure with a reprocessed ep diagnostic catheter livewire deca extra large curl and there was a separation where the last electrode connects to the shaft of the catheter with internal components exposed.Multiple attempts have been completed to obtain product return status or tracking information, to no avail.A manufacturing record evaluation was performed, and no internal actions related to the complaint were found during the review.No device was received for analysis at this time.Since the product was not returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors could be made.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: EP DIAGNOSTIC CATHETER LIVEWIRE DECA EXTRA LARGE CURL
• 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13002698
• Report Number: 2134070-2021-00031
• Device Sequence Number: 4216970
• Product Code: NLH
• UDI-Device Identifier: 10888551008990
• UDI-Public: 10888551008990
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K051220
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• 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: 04/01/2022
• Device Model Number: DAI401941
• Device Catalogue Number: DAI401941
• Device Lot Number: 2142912
• 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: 11/23/2021
• Supplement Date Received by Manufacturer: 01/14/2022
• Initial Report FDA Received Date: 12/14/2021
• Supplement Report FDA Received Date: 01/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2021
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown