MAUDE Adverse Event Report: PFM MEDICAL AG NIT-OCCLUD PDA; PDA OCCLUDER

Model Number 145054V2

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)

Patient Problems Embolism (1829); Foreign Body In Patient (2687)

Event Date 11/08/2019

Event Type  malfunction  

Manufacturer Narrative

The complaint was forwarded to the manufacturer and investigated.The device history record (dhr) has been reviewed and showed no deviations.Since neither samples, nor film or picture material were available for an investigation, but only the present description and the production documents did not show any deviations, the evaluation was concluded on the basis of the information available.The cause of the defect cannot be determined.After production, the system was 100% checked by the employees and qa and was in compliance with the specification.Complaint determined reportable on 01/30/2020.

Event Description

Physician performed a standard pda procedure, measured and decided to use a 5x4 nit-occlud.Physician followed all ifu instructions before release and after deployment saw that there was still residual flow through the ductus.After waiting an additional five minutes, there was still flow.Physician went up with a catheter to see if an additional coil could be put in to stop the flow.While working with the catheter around the nit-occlud, it became dislodged and went into the tricuspid valve.When the coil was retrieved and out of the body, the coil was coming off of the inner core wire.This may have happened in the snaring process.Physician used a snare to get it out and then used an amplatzer to close the pda.Measured ductus size (mm): aortic 3.2, pulmonary 1.3, length 3.9.Procedure duration: 128 minutes.Pda access: venous and aortal.A cook 7f introducer sheath was used.Heparin (systemic) iu/kg: 1500 units - don't give heparin but because of the issue they did.They use a manifold bag.The physician did not notice high resistance during forwarding or retrieval of the system into the implantation catheter.Curvature of implantation catheter in the vessel was straight.The physician did no notice a gap between pusher and coil prior to release.The physician moved the rotation screw 8-15 revolutions forward for release.

• Brand Name: NIT-OCCLUD PDA
• Type of Device: PDA OCCLUDER
• Manufacturer (Section D): PFM MEDICAL AG; wankelstrasse 60; 50996 cologne, ; GM
• Manufacturer (Section G): PFM MEDICAL AG; wankelstrasse 60; 50996 cologne, ; GM
• Manufacturer Contact: troy taylor ; 1916 palomar oaks way; suite 150; carlsbad, CA 92008 ; 7607588749
• MDR Report Key: 9668243
• MDR Text Key: 205520271
• Report Number: 2032582-2020-00001
• Device Sequence Number: 1
• Product Code: MAE
• UDI-Device Identifier: 04042301159953
• UDI-Public: 04042301159953
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/17/2020
• Device Model Number: 145054V2
• Device Catalogue Number: 145054V2
• Device Lot Number: 1023387
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2017
• 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): Required Intervention
• Patient Age: 44 MO
• Patient Weight: 15