MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION HARMONY DELIVERY CATHETER SYSTEM; PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELI

Model Number	HARMONY-DCS
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that during a transcatheter procedure involving the harmony¿ delivery catheter system, damage was noted to the delivery catheter system, specifically with the side port, prior to insertion into the patient.The issue was identified while opening the capsule prior to loading.An additional stop cock was attached as a response to the issue.No patient complications have been reported as a result of this event.
Event or Problem Description
It was reported that during a transcatheter procedure involving the harmony¿ delivery catheter system (dcs), damage was noted to the dcs, specifically with the side port, prior to insertion into the patient.The issue was identified while opening the capsule prior to loading.An additional stop cock was attached as a response to the issue.No patient complications have been reported as a result of this event.Additional information was received to clarify the stopcock was replaced and the dcs was used for the case.
Additional Manufacturer Narrative
Updated data: b5.A second paragraph was added.Corrected data: d.Suspect medical device expiration date was inadvertently omitted from the initial medwatch report.Udi#.Full number included h4.Device mfg date was inadvertently omitted from the initial medwatch report.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Additional information: b5 (third paragraph).Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that during a transcatheter procedure involving the harmony¿ delivery catheter system (dcs), damage was noted to the dcs, specifically with the side port, prior to insertion into the patient.The issue was identified while opening the capsule prior to loading.An additional stopcock was attached as a response to the issue.No patient complications have been reported as a result of this event.Additional information was received to clarify the stopcock was replaced and the dcs was used for the case.Additional information was received clarifying that just the stopcock was replaced, and the replacement part was obtained from the facility's inventory.

• Brand Name: HARMONY DELIVERY CATHETER SYSTEM
• Common Device Name: PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELI
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 21313982
• Report Number: 2025587-2025-01002
• Device Sequence Number: 8169438
• Product Code: NPV
• UDI-Device Identifier: 00763000341367
• UDI-Public: (01)00763000341367(17)250718(10)0012364480
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P200046
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/07/2025

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: 07/18/2025
• Device Model Number: HARMONY-DCS
• Device Catalogue Number: HARMONY-DCS
• Device Lot Number: 0012364480
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2025
• Supplement Date Received by Manufacturer: 02/26/2025; 03/11/2025
• Initial Report FDA Received Date: 02/05/2025
• Supplement Report FDA Received Date: 03/10/2025; 04/07/2025
• Date Device Manufactured: 07/18/2024
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 20 YR
• Patient Sex: Female
• Patient Weight: 60 KG