MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER GUIDEWIRE; WIRE, GUIDE, CATHETER

Catalog Number	9-GW-002
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Perforation (2001); Pericardial Effusion (3271)
Date of Event	05/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2024, a 6mm amplatzer muscular vsd occluder was chosen to close a ventricular septal defect using a 6f amplatzer torqvue delivery system.Heparin was administered, and the patient's activated clotting time (act) level was 230 seconds.Closure of the defect was performed without difficulty implanting the device.On echocardiographic review, a pericardial effusion was evident.A perforation of the right ventricle in the anterior area was noted.Pericardiocentesis was required for the pericardial effusion, and 160cc were drained.Open heart surgery was required to repair the perforation.The physician believed that the pericardial effusion was possibly caused by the non-abbott catheter or abbott guidewire used to access the right ventricle.The patient status was reported as stable.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of use-related tissue damage and pericardial effusion was reported.Reportedly, the patient required pericardiocentesis and surgical intervention to treat the perforation.A returned device 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 specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• Brand Name: AMPLATZER GUIDEWIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• 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: 19441088
• Report Number: 2135147-2024-02513
• Device Sequence Number: 8299388
• Product Code: DQX
• UDI-Device Identifier: 00811806010724
• UDI-Public: (01)00811806010724(17)281231(10)9943937
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K053187
• 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): 07/23/2024

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 Catalogue Number: 9-GW-002
• Device Lot Number: 9943937
• 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: 05/08/2024
• Supplement Date Received by Manufacturer: 07/02/2024
• Initial Report FDA Received Date: 05/31/2024
• Supplement Report FDA Received Date: 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/12/2024
• 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: AMPLATZER MUSCULAR VSD OCCLUDER, 9-VSD-MUSC-006; AMPLATZER TORQVUE DELIVERY SYSTEM, 9-ITV06F180/80; TERUMO CATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 10 YR
• Patient Sex: Female
• Patient Weight: 33 KG