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

Catalog Number	9-TVLPC4F90/080
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2024
Type of Reportable Event	Malfunction
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 that on (b)(6) 2024, a 4mm by 4mm amplatzer piccolo occluder was chosen for implant using a 4f amplatzer torqvue low profile catheter.During procedure, the physician attempted to release the device, but the device would not lock into the cable to allow the cable to turn in unison with the device.The device was released from the cable by utilizing a hemostat to turn the cable.The device was implanted.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.The patient was reported recovering.
Event or Problem Description
It was reported that on (b)(6) 2024, a 4mm by 4mm amplatzer piccolo occluder was chosen for implant using a 4f amplatzer torqvue low profile catheter.During procedure, the physician attempted to release the device, but the device would not lock into the cable to allow the cable to turn in unison with the device.The device was released from the cable by utilizing a hemostat to turn the cable.The device was implanted.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.The patient was reported recovering.
Additional Manufacturer Narrative
An event of device difficult to setup (failure to connect) was reported.The investigation confirmed the device met functional specifications when analyzed at abbott.No anomalies were found.In addition, the coil on the delivery wire was noted to contained a small deformation.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 available information, a cause for the reported event could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• Brand Name: AMPLATZER TORQVUE LP
• 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: 19182300
• Report Number: 2135147-2024-01840
• Device Sequence Number: 17962033
• Product Code: DQY
• UDI-Device Identifier: 00811806012926
• UDI-Public: (01)00811806012926(17)260630(10)9078966
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K131063
• 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
• Report Date (Section B): 05/07/2024

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 Expiration Date: 06/30/2026
• Device Catalogue Number: 9-TVLPC4F90/080
• Device Lot Number: 9078966
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/01/2024
• Supplement Date Received by Manufacturer: 05/07/2024
• Initial Report FDA Received Date: 04/25/2024
• Supplement Report FDA Received Date: 05/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2023
• 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
• Patient Sex: Unknown