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

Model Number 9-GW-002

Device Problems Difficult to Insert (1316); Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/22/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

On (b)(6) 2020, an amplatzer guidewire was selected for use during an laao procedure.After trans-septal puncture, the physician inserted the guidewire into the slpv.The physician attempted to insert the delivery sheath over the guidewire, however it was not possible due to an imperfection on the guidewire.The guidewire was removed and a new amplatzer guidewire was used to successfully implant the 28mm amplatzer amulet.The imperfection on the guidewire was observed after the guidewire had been inserted into the left pulmonary vein.The patient was hemodynamically stable throughout the procedure and the physician denies a tortuous patient anatomy.The physician does allege a prolonged procedure time.

Manufacturer Narrative

An event of inability to insert the delivery sheath over the guidewire due to an imperfection could not be confirmed.The guidewire met functional specifications when analyzed at abbott.A blue piece of foreign material was noted between the coils of the guidewire and a few of the outer coils were noted to be slightly out of alignment.The device was manufactured according to specifications as supported by the receiving inspection results.The cause of the reported event could not be conclusively determined.

Manufacturer Narrative

Corrected information section: h6.

• Brand Name: AMPLATZER GUIDEWIRE
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 9716638
• MDR Text Key: 181821473
• Report Number: 2135147-2020-00030
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• PMA/PMN Number: K935170
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 9-GW-002
• Device Catalogue Number: 9-GW-002
• Device Lot Number: 9940115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention