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	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon receipt at medtronic¿s quality laboratory, the hemostatic actuator and the proximal handle were intact.The proximal handle rotated on the proximal end of the delivery catheter system (dcs).The distal tip could be advanced until the luer touched the proximal handle edge.The hemostasis actuator locked when rotated clockwise and unlocked when rotated counterclockwise.The proximal handle actuator locked when rotated clockwise and unlocked when rotated counterclockwise.The device was received with the capsule fully closed.The device was received with the capsule support tube loaded on the dcs.Some resistance was experienced while removing the capsule support tube from the dcs.A separation was observed in the capsule near the proximal end of the capsule.The separation site was observed to be at the capsule proximal bond region and the separation site appears even and smooth.The dcs coil and the guidewire luer were intact and no evidence of damage.The device was returned with the capsule separated, therefore confirming the reported event.Conclusion: the subject delivery catheter system (dcs) was returned to the analysis lab.The dcs was observed to have a separation site at the capsule proximal bond region and the separation site appeared even and smooth.Resistance encountered while removing the capsule support tube is likely due to the leading edge which is noted at the separation site on this damaged capsule.A device history record (dhr) review was performed on the dcs and there were no correlations/issues identified regarding manufacturing.The device was manufactured per approved and released manufacturing processes and the device met all applicable manufacturing specifications prior to release for distribution.The dhr review did not show any findings related to this event.This dcs experienced capsule break while in medtronic control and did not occur in any clinical cases, therefore no adverse patient effects were reported.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that during bench demonstration in peer-to-peer training, a delivery catheter system (dcs) capsule bond break occurred after two to three uses in the water bath.The capsule break occurred while in medtronic control and did not occur in a clinical case, therefore no adverse patient effects were reported.
Additional Manufacturer Narrative
Corrected data: g3 was updated to reflect the accurate aware date.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• 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: 15126468
• Report Number: 2025587-2022-02130
• Device Sequence Number: 5446996
• Product Code: NPV
• UDI-Device Identifier: 00763000341367
• UDI-Public: 00763000341367
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P200046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2024

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: 08/31/2022
• Device Model Number: HARMONY-DCS
• Device Catalogue Number: HARMONY-DCS
• Device Lot Number: 0010826598
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2022
• Supplement Date Received by Manufacturer: 03/19/2022
• Initial Report FDA Received Date: 07/28/2022
• Supplement Report FDA Received Date: 01/24/2024
• Date Device Manufactured: 08/31/2021
• 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): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0927-2022
• Patient Sequence Number: 1
• Patient Sex: Unknown