MAUDE Adverse Event Report: PFM MEDICAL INC. NIT-OCCLUD PDA; OCCLUDER, PATENT DUCTUS, ARTERIOSUS

Model Number	145096V2
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Embolism (1829); Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Date of Event	03/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device performed within specification.Event attributed to user error.
Event or Problem Description
Patient admitted for right and left heart catheterization, angiograms -lv, ao, multiple angiograms at aortic isthmus, and device closure of patent ductus arteriosus.Nit-occlud dislodged out of pda and was stuck in the tricuspid valve.Nit-occlud left in the tricuspid valve area.Pda closure obtained with vascular plug ii 8mm; no residual patent ductus arteriosus.Attempt made at removal of nit-occlud by transcatheter technique unsuccessful.Us peds echo post incident - coil device is displaced within the tricuspid valve annulus, device appears stable with no obstruction to flow.Echo repeated twice more with continued report of stability with no obstruction to flow.The patient was discharged on (b)(6) 2018 in stable condition.Pda access was venous.Account states that this was not a device error, but an operational error.No other information is being made available by the account.

• Brand Name: NIT-OCCLUD PDA
• Common Device Name: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• Manufacturer (Section D): PFM MEDICAL INC.; 1916 palomar oaks way; suite 150; carlsbad CA 92008
• MDR Report Key: 7466296
• Report Number: 2032582-2018-00001
• Device Sequence Number: 16414994
• Product Code: MAE
• UDI-Device Identifier: 04042301160010
• UDI-Public: 04042301160010
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P120009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/26/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/25/2020
• Device Model Number: 145096V2
• Device Catalogue Number: 145096V2
• Device Lot Number: 1021613
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2018
• Initial Report FDA Received Date: 04/26/2018
• 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: Other
• Patient Age: 3 YR
• Patient Weight: 12