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

Model Number	145096V2
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/04/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record (dhr) has been reviewed and showed no deviations.The information you provided was used to conduct an investigation.The investigation showed that the safety clip was not removed and the release mechanism was not engaged.Thus, the reason for rejection can be confirmed.On the supplied x-ray it seems that the coil is separated from the carrier.Furthermore, it can be seen that two windings are released, then several angiographs were taken and then even the coil sits in position.The configuration of the coil between two redundant windings and the coil in its final position is not visible on the film.The exact reason why it came to this complaint cannot be recognized.A corrective action is not necessary because the error has been evaluated in the risk analysis and is classified as acceptable.The complaint is justified.
Event or Problem Description
The coil was not attached.Upon deployment, the coil curled through the pigtail catheter.When physician tried to resheath, it was discovered that the coil was not attached.Only about 1 third of the coil was out.There was no problem during the prep or insertion of the device into the catheter.The nit-occlud did move to the proper positions.

• Brand Name: NIT-OCCLUD PDA
• Common Device Name: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• Manufacturer (Section D): PFM MEDICAL AG; wankelstrasse 60; köln, nordrhein-westfalen 50996 ; GM 50996
• MDR Report Key: 8313017
• Report Number: 2032582-2016-00006
• Device Sequence Number: 19382761
• Product Code: MAE
• UDI-Device Identifier: 04042301160010
• UDI-Public: 04042301160010
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P120009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 145096V2
• Device Catalogue Number: 145096V2
• Device Lot Number: 1014647.01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2016
• Initial Report FDA Received Date: 02/06/2019
• 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