MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER TORQVUE DELIVERY SYSTEM; CATHETER, PERCUTANEOUS

Catalog Number	9-ITV05F180/60
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Codes	Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	08/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported on (b)(6) 2024, a 5mm x 4mm amplatzer piccolo occluder was chosen for implantation using a 4f amplatzer torqvue delivery catheter for a 1 month old 2 kilogram patient to treat a patent ductus arteriosus (pda) that was measured with a minimum diameter of 3.6mm and a length of 6.3mm.During implant the device was unstable and slipped on the side of the pulmonary artery.Two re-positions were attempted with no optimal results.The occluder and delivery catheter were removed from the patient and replaced with a new 8mm amplatzer vascular plug ii and 5f amplatzer torqvue delivery system.During implant the plug was unstable.The plug was removed from the patient and replaced with a new non-abbott device using the same delivery system.During implant the device was unstable and slipped into the pulmonary side.The device was removed from the patient.After the delivery sheath was removed, the patient presented with a cardiac tamponade.A pericardiocentesis was performed and 10ml of fluid was drained.The user suspected the 5f delivery system may have been damaged after loading the non-abbott device and caused the cardiac tamponade.The patient remained in the intensive care unit (icu) for monitoring.
Event or Problem Description
It was reported on (b)(6) 2024, a 5mm x 4mm amplatzer piccolo occluder was chosen for implantation using a 4f amplatzer torqvue delivery catheter for a 1 month old 2 kilogram patient to treat a patent ductus arteriosus (pda) that was measured with a minimum diameter of 3.6mm and a length of 6.3mm.The patient was noted to have complex anatomy.During implant the device was unstable and slipped on the side of the pulmonary artery.Two re-positions were attempted with no optimal results.The occluder and delivery catheter were removed from the patient and replaced with a new 8mm amplatzer vascular plug ii and 5f amplatzer torqvue delivery system.During implant the plug was unstable and was protrusive in the aorta.The plug was removed from the patient and replaced with a new non-abbott device using the same delivery system.During implant the device was unstable and slipped into the pulmonary side.The device was removed from the patient.After the delivery sheath was removed, the patient presented with a cardiac tamponade.A pericardiocentesis was performed and 10ml of fluid was drained.The user suspected the 5f delivery system may have been damaged after loading the non-abbott device and caused the cardiac tamponade.The patient remained in the intensive care unit (icu) for monitoring.
Additional Manufacturer Narrative
H6.Medical device problem code: [2017 - improper or incorrect procedure or method] was removed.It was reported during implant the plug was unstable and was removed from the patient; after the delivery sheath was removed, the patient presented with a cardiac tamponade.Field indicated that the patient was noted to have complex anatomy and two re-positions were attempted with no optimal results with amplatzer piccolo occluder before attempting to implant avp2 plug.Reportedly, during implant the plug was unstable and was protrusive in the aorta, so the plug was removed from the patient and replaced with a new non-abbott device using the same delivery system.Please note that per the instructions for use, artmt600034291-b, "warnings: this device was sterilized with ethylene oxide and is for single use only.Do not reuse or resterilize this device.Attempts to resterilize this device can cause a malfunction, insufficient sterilization, or harm to the patient." information from field indicated that, the user suspected the delivery system may have been damaged after loading the non-abbott device and caused the cardiac tamponade.The device was not returned to abbott for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.It is possible that the operational difficulties and reuse of device may have contributed to the reported patient effects of pericardial effusion and cardiac tamponade, however could not be conclusively determined.The reported intervention was a result of case-specific circumstances as a pericardiocentesis was performed and 10ml of fluid was drained.The patient remained in the intensive care unit for monitoring.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 TORQVUE DELIVERY SYSTEM
• Common Device Name: CATHETER, PERCUTANEOUS
• 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: 20127171
• Report Number: 2135147-2024-04326
• Device Sequence Number: 3187297
• Product Code: DQY
• UDI-Device Identifier: 00811806010755
• UDI-Public: (01)00811806010755(17)260630(10)9151049
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K072313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2026
• Device Catalogue Number: 9-ITV05F180/60
• Device Lot Number: 9151049
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/09/2024
• Supplement Date Received by Manufacturer: 10/01/2024
• Initial Report FDA Received Date: 09/03/2024
• Supplement Report FDA Received Date: 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/22/2023
• 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: 8MM AMPLATZER VASC PLUG 2[9-AVP2-008, LOT 9184773]; AMPLATZER PICCOLO OCCLUDER, 9-PDAP-05-04-L; AMPLATZER VASCULAR PLUG II, 9-AVP2-008
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention; Hospitalization
• Patient Age: 1 MO
• Patient Sex: Unknown
• Patient Weight: 2 KG