MAUDE Adverse Event Report: Abbott Medical Amplatzer Piccolo¿ Delivery System; Catheter Delivery System

Model Number	9-PDS-04F-045
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Pericardial Effusion (3271)
Date of Event	09/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2026, a 4f amplatzer piccolo delivery system was chosen for a patent ductus arteriosus (pda) closure procedure on a 3week old, 1000grams premature infant.During procedure, the right femoral vein access was achieved in the usual manner and a 4f access sheath was placed.A non-abbott wire and piccolo delivery system (pds) combination was advanced up the inferior vena cava (ivc), across the tricuspid valve towards the right ventricular outflow tract (rvot) and into the pulmonary artery(pa).The non-abbott wire was advanced in an attempt to engage the pda, but would not track down the descending aorta.The non-abbott wire was then exchanged for an another non-abbott glide wire which took an unusual course and appeared to be in the pericardial space.The baby was stable at this point.The glide-wire and pds was then withdrawn back into the ivc at which point the baby become hypotensive and tachycardic.A transthoracic echocardiogram (tte) assessment was done and revealed a rapidly accumulating 5mm circumferential pericardial effusion.The glide wire and pds was then removed from the body and a pericardiocentesis was performed.A 8ccs of blood was removed from the pericardial space and the blood pressure and heart rate returned back to baseline.The baby was monitored for another 45 minutes during which time a pericardial drain was placed.During this time the baby remained stable and there was no re-accumulation of fluid was noted.Another tee assessment was preformed and revealed no re-accumulation of pericardial fluid, normal heart function, no significant valvular regurgitation and a persistent pda.There were no further attempts at pda closure was made, and the baby returned to the neonatal intensive care unit (nicu) in stable condition.The physician reported that the baby was stable and doing well on follow-up the next day.
Additional Manufacturer Narrative
The device remains implanted in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

• Brand Name: Amplatzer Piccolo¿ Delivery System
• Common Device Name: Catheter Delivery System
• 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 ; +1(651)756-5400
• MDR Report Key: 50897010
• Report Number: 2135147-2026-06493
• Device Sequence Number: 5904091
• Product Code: DQY
• UDI-Device Identifier: 05415067052926
• UDI-Public: (01)05415067052926
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K252417
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 9-PDS-04F-045
• Device Catalogue Number: 9-PDS-04F-045
• Device Lot Number: 11327487
• 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: 09/01/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/26/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other; Disability
• Patient Age: 21 DA
• Patient Sex: Male
• Patient Weight: 2 LB