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

Model Number	145054V2
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)
Health Effect - Clinical Codes	Embolism (1829); Foreign Body In Patient (2687)
Date of Event	11/08/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: PDA OCCLUDER
• Manufacturer (Section D): PFM MEDICAL AG; wankelstrasse 60; 50996 cologne, ; GM
• MDR Report Key: 9668243
• Report Number: 2032582-2020-00001
• Device Sequence Number: 2668449
• Product Code: MAE
• UDI-Device Identifier: 04042301159953
• UDI-Public: 04042301159953
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P120009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2019
• Initial Report FDA Received Date: 02/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 44 MO
• Patient Weight: 15