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

Model Number 9-ITV10F45/80

Device Problem Material Perforation (2205)

Patient Problems Perforation (2001); Pericardial Effusion (3271)

Event Date 07/17/2019

Event Type  Injury  

Manufacturer Narrative

Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

On (b)(6) 2019, a 16mm amplatzer muscular vsd occluder was selected for implant.The procedure was complex as the patient's defect was very apical.There was also the presence of a pseudo-aneurysm located on the lateral wall of the vd (ventricle defect) and a litany of trabeculations.As the physician was getting ready to deploy the device and a pericardial effusion on the lateral side of the vd was noted.The physician quickly deployed the occluder and punctured the pericardium.220cc of blood was extracted and after 125 minutes, a pericardial drain was set in place and the bleeding stopped.The procedure took longer than anticipated.The patient is reported to be in stable condition.Manufacturer report number: 2135147-2019-00223.

Manufacturer Narrative

Correction: upon review, the delivery system should not have been submitted as a medical device report (mdr) as the event did not indicate a malfunction caused a serious event.

• Brand Name: AMPLATZER TORQVUE DELIVERY SYSTEM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 8865392
• MDR Text Key: 153538162
• Report Number: 2135147-2019-00224
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00811806010878
• UDI-Public: 00811806010878
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K072313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: 9-ITV10F45/80
• Device Catalogue Number: 9-ITV10F45/80
• Device Lot Number: 7043953
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 86 YR
• Patient Weight: 66