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

Model Number	9-TVLPC4F90/080
Medical Device Problem Codes	Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)
Date of Event	09/29/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
The results, method, and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
It was reported that on 29 sep.2021, that a 3/2 amplatzer piccolo occluder was selected for implant using a 4 f amplatzer torqvue lp catheter.The patient was 25 days old, 650 g, with patent ductus arteriosus (pda) dimensions of: minimal diameter 1.77 mm.During the procedure it was difficult to traverse into pulmonary artery (pa) and across the pda.Once across the pda defect a catheter exchange was performed for the torqvue lp catheter.At this time the patient blood pressure (bp) started dropping a bit and the heart rate increased.The physician thought that the catheter was possibly depressed against the valve.The pda was sized and the 3/2 amplatzer piccolo occluder was deployed intraductal and released.Once the device was released a transthoracic echocardiogram (tte) was performed and revealed a pericardial effusion.The team spent hours working on the patient but they unfortunately expired on 29 sep.2021.The physician alleges that the cause of death was likely due to the patients comorbidities.No additional information was provided.
Additional Manufacturer Narrative
An event of difficulty traversing the pulmonary artery, pericardial effusion, and patient death was reported.A more comprehensive assessment 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.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: AMPLATZER TORQVUE LP CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12719356
• Report Number: 2135147-2021-00454
• Device Sequence Number: 11760183
• Product Code: DQY
• UDI-Device Identifier: 00811806012926
• UDI-Public: 00811806012926
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K162228
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2021

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 Expiration Date: 07/31/2024
• Device Model Number: 9-TVLPC4F90/080
• Device Catalogue Number: 9-TVLPC4F90/080
• Device Lot Number: 8090701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2021
• Supplement Date Received by Manufacturer: 12/01/2021
• Initial Report FDA Received Date: 10/29/2021
• Supplement Report FDA Received Date: 12/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2021
• 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: Death
• Patient Age: 25 DA
• Patient Sex: Female
• Patient Weight: 1 KG