MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER PICCOLO; OCCLUDER, PATENT DUCTUS, ARTERIOSUS

Model Number	9-PDAP-05-04-L
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2024, a 5 mm x 4 mm amplatzer piccolo occluder was chosen for implant using a amplatzer torqvue lp delivery system.During procedure, the physician was unable to detach the device from the delivery cable and attempted to lock the set screw on the vise down to the cable but the cable was unable to connect the vise, it just spin.The physician was able to successfully release the device using a hemostat but the device moved a bit on the release but in the end was fine.There was no complaint on hemodynamics was reported but patient required more anesthesia time and time out of incubator.The patient was reported healing in (neonatal intensive care unit) nicu in standard fashion.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
It was reported that there was a separation problem of device from the delivery cable during procedure.Also reported that the device was successfully released using a hemostat but the device moved a bit upon release.A more comprehensive assessment to rule out any device-related causes, could not be performed as the device was not returned for analysis.The cause of separation problem could not be conclusively determined.Based on the information received, the cause of reported device migration is possibly related to operational difficulty due to separation problem.The patient was reported healing in neonatal intensive care unit.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.There were no complaints associated with any other devices from the lot.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
An event of separation problem of device from the delivery cable and difficulty connecting the vise onto delivery cable was reported.Also reported that the device was successfully released using a hemostat but the device moved a bit upon release.A more comprehensive assessment to rule out any device-related causes, could not be performed as the device was not returned for analysis.The cause of separation problem could not be conclusively determined.Based on the information received, the cause of reported device migration is possibly related to operational difficulty due to separation problem.The patient was reported healing in neonatal intensive care unit.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.There were no complaints associated with any other devices from the lot.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• Brand Name: AMPLATZER PICCOLO
• Common Device Name: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 21120612
• Report Number: 2135147-2025-00240
• Device Sequence Number: 21003336
• Product Code: MAE
• UDI-Device Identifier: 05415067031044
• UDI-Public: (01)05415067031044(17)290131(10)10231779
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: P020024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 07/10/2025

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 Model Number: 9-PDAP-05-04-L
• Device Catalogue Number: 9-PDAP-05-04-L
• Device Lot Number: 10231779
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/16/2024
• Supplement Date Received by Manufacturer: 03/06/2025; 06/25/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 03/17/2025; 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/29/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED.
• Patient Sex: Unknown