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

Model Number	9-ITV07F180/80
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported on (b)(6) 2025 a 6mm x 4mm amplatzer duct occluder ii was selected for implant using a 6f amplatzer torqvue delivery system to close a patent ductus arteriosus (pda).The devices were prepared per ifu.The cable connection was checked 2-3 times.Angiography was used to determine device sizing.During the implant the occluder was advanced 5cm from the delivery sheath and prematurely released from the delivery cable.The location of the device was confirmed to still be inside the delivery system.A scalpel was used to cut in front of the location of the device to retrieve it.The delivery system was replaced with a new 7f amplatzer torqvue delivery system.The same occluder was used with the 7f delivery system to complete the procedure.The patient did not present with any clinical signs or symptoms.The patient status was stable.
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of premature separation was reported.A returned device inspection, to rule out any device-related causes, could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on the information received, the cause of the reported incident could not be conclusively determined.The reported unexpected medical intervention was a result of case-specific circumstances as a cut was done in front of the location of the device to retrieve it.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
It was reported on (b)(6) 2025 a 6mm x 4mm amplatzer duct occluder ii was selected for implant using a 6f amplatzer torqvue delivery system to close a patent ductus arteriosus (pda).The devices were prepared per ifu.The cable connection was checked 2-3 times.Angiography was used to determine device sizing.During the implant the occluder was advanced 5cm from the delivery sheath and prematurely released from the delivery cable.The location of the device was confirmed to still be inside the delivery system.A scalpel was used to cut in front of the location of the device to retrieve it.The delivery system was replaced with a new 7f amplatzer torqvue delivery system.The same occluder was used with the 7f delivery system to complete the procedure.The patient did not present with any clinical signs or symptoms.The patient status was stable.
Additional Manufacturer Narrative
An event of premature separation was reported.The device was returned to abbott and confirmed to meet functional specifications.The sheath was received cut in two separate pieces, which is consistent with the reported event, as the sheath was cut during the procedure to retrieve the occluder.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on the information received, the cause of the reported incident could not be conclusively determined.The reported unexpected medical intervention was a result of case-specific circumstances as a cut was made in front of the location of the device to retrieve it.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: 21961638
• Report Number: 2135147-2025-02373
• Device Sequence Number: 7265740
• Product Code: DQY
• UDI-Device Identifier: 00811806010793
• UDI-Public: (01)00811806010793(17)270430(10)10352014
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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,Followup
• Report Date (Section B): 02/25/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 9-ITV07F180/80
• Device Catalogue Number: 9-ITV07F180/80
• Device Lot Number: 10352014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2025
• Supplement Date Received by Manufacturer: 07/30/2025; 02/02/2026
• Initial Report FDA Received Date: 05/05/2025
• Supplement Report FDA Received Date: 08/07/2025; 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2024
• 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: 6MM X 4MM AMPLATZER DUCT OCCLUDER II[9-PDA2-06-04]
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 5 YR
• Patient Sex: Male
• Patient Weight: 22 KG