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	02/15/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided was used to conduct an investigation.It was reported that the coil jumped forward during the configuration and got stuck in the aorta.The coil was badly positioned with a few windings in the pda.It was also reported that the coil jumped in the pda.It was also reported that there was no resistance or gap noticed before releasing the coil.A gap is not present during releasing.According to the user the rotating square was not pressed, even though the safety clip was removed.The coil was retrieved with a snare and the defect was closed with an amplatzer device.During the inspection in the production an ejection force of 24.2 n was measured.The already deformed coil was reassembled and a new drop test was performed.The results here was 19.8 n.A corrective action is not necessary because the error has been evaluated in the risk analysis and is classified as acceptable.This complaint is unjustified.
Event or Problem Description
Premature deployment.Physician was positioning the nit-occlude in the pda when the device, "popped off." the device jumped forward but not completely into the aorta.Physician was able to snare the device out and placed an amplatzer device.The curvature of implantation catheter in the vessel was mild.The physician did not notice a gap between pusher and coil prior to release.The physician did not move the rotation screw forward at all.When the device deployed on its own, it jumped forward and was poorly positioned in the pda with many coil hanging out into the aorta.

• 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: 8313046
• Report Number: 2032582-2016-00007
• Device Sequence Number: 2288495
• Product Code: MAE
• UDI-Device Identifier: 04042301160010
• UDI-Public: 04042301160010
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P120009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• 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?: No
• Operator of Device: Health Professional
• Device Model Number: 145096V2
• Device Catalogue Number: 145096V2
• Device Lot Number: 1013937.02
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2016
• 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
• Patient Age: 15 MO
• Patient Weight: 9