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

Model Number	9-PDAP-05-04-L
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2024, a 5mm by 4mm amplatzer piccolo occluder was chosen for implant using a 4f amplatzer torqvue lp delivery system.During the attempt to release the occluder, delivery cable and plastic vise were inoperable in the delivery system.When the physician attempted to unscrew the fore mentioned piccolo from the torqvue system the plastic vise just slide around the cable.The physician tried to re-tighten the vise to the cable and the set screw was hubbed out and would still not contact the cable.After inspection of the cable it was noted, the vise would just slide off the cable and not make contact with the vise set screw fully tightened down.The patient was hemodynamically stable and the physician used a guidewire torquer device to unscrew the device from the cable and implanted the piccolo occluder.There was some delay in the patient care, only a few minutes but the aby tolerated that portion well.The patient was reported recovering in normal fashion.
Additional Manufacturer Narrative
An event of separation problem was reported.It was indicated that when tried to re-tighten the vise to the cable and the set screw was hubbed out and would still not contact the cable.The device was received for investigation and found a damage was noted on the sheath.The delivery cable was noted to have deformation damage on the coil.When analyzed under non-physiological conditions.The screw was measured using a caliper and met measurement specification.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.The cause of the noted damage might caused due to procedural conditions, but reported event could be due to event could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
Additional Manufacturer Narrative
An event of failure to connect the device and separation problem was reported.It was indicated that when tried to re-tighten the vise to the cable and the set screw was hubbed out and would still not contact the cable.The device was received for investigation and found a damage was noted on the sheath.The delivery cable was noted to have deformation damage on the coil.When analyzed under non-physiological conditions.The screw was measured using a caliper and met measurement specification.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.The cause of the noted damage might caused due to procedural conditions, but reported event could be due to event could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.Codes removed: component code: 568 screw.Codes added: medical device problem code 1487.Component code 4775.

• 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: 21536091
• Report Number: 2135147-2025-01121
• Device Sequence Number: 20596844
• Product Code: MAE
• UDI-Device Identifier: 05415067031044
• UDI-Public: (01)05415067031044(17)280630(10)9172605
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P020024
• 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
• Report Date (Section B): 10/31/2025

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: 9172605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/12/2025
• Supplement Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 03/06/2025
• Supplement Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2023
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 4F AMPLATZER TORQVUE LP DELIVERY SYSTEM.
• Patient Age: 8 MO
• Patient Sex: Female
• Patient Weight: 2 KG