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

Catalog Number	9-TVLPC4F90/080
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Tricuspid Valve Insufficiency/ Regurgitation (4453)
Date of Event	05/02/2024
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 that on (b)(6) 2024, a amplatzer piccolo occluder 4 mm x 2 mm was selected for an implant using a 4f amplatzer torqvue low profile catheter.During standard placement process of piccolo device, the physician noted moderate tricuspid regurgitation following piccolo placement and standard echocardiogram imaging.After the procedure a thorough echocardiogram was completed and tricuspid valve regurgitation was noted.The physician believed the occluder was damaged from the non-abbott catheter or the 4f amplatzer torqvue low profile catheter.He stated he felt a slight hang up as he was passing the 4f amplatzer torqvue low profile catheter over the non-abbott wire.He assumed the damage occured during this point in the procedure based on the slight pressure felt during this catheter exchange and initial insertion of the4f amplatzer torqvue low profile catheter over the non-abbott wire.The device was explanted, it is unknown if a new device was implanted.The patient is stable.
Additional Manufacturer Narrative
An event of moderate tricuspid regurgitation following piccolo placement and occluder damage due to catheter exchange and initial insertion of catheter over guidewire was reported.A returned device assessment could not be performed as the device was not returned for analysis.No additional information was provided.Based on the information received, the cause of the reported incident could not be conclusively determined.

• 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: 19396550
• Report Number: 2135147-2024-02401
• Device Sequence Number: 15376032
• Product Code: DQY
• UDI-Device Identifier: 00811806012926
• UDI-Public: 00811806012926
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K131063
• 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): 07/10/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 9-TVLPC4F90/080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/02/2024
• Supplement Date Received by Manufacturer: 06/28/2024
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Age: 28 DA
• Patient Sex: Female