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

Model Number	145076V2
Medical Device Problem Code	Unintended Ejection (1234)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/22/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
"he" device history record (dhr) has been reviewed and showed no deviations.The information you provided was used to conduct an investigation.First, a drop test was carried out with the result of 23.76 n.The coil was fine.In the interim review an ejection force of 25.2 n was measured.The images of the included recordings show the coil in the defect.In the angiography a complete occlusion was recognized.Nevertheless, the user replaced the coil again, with the result that the coil dissolved.A corrective action is not necessary because the error has not been caused by the product or procedure.
Event or Problem Description
The coil separated from the delivery system while in the catheter.It was retrieved without incident.Physician configured coil in the descending aorta, pulled system back into defect, suspected potential coarc and decided to retrieve / re-configure.Upon sheath re-entry, coil detached from mandrel wire.A 5x4 ado i was used to complete the procedure.Physician did not notice high resistance during forwarding or retrieval of the system into the implantation catheter.Curvature of the implantation catheter in the vessel was mild.The physician did not notice a gap between the pusher and coil prior to release.The physician did not move the rotation screw forward at all.In the film, a gap is noticeable between the pusher wire and the device; approximately 1cm or more.

• 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: 8313083
• Report Number: 2032582-2016-00009
• Device Sequence Number: 206573
• Product Code: MAE
• UDI-Device Identifier: 04042301159991
• UDI-Public: 04042301159991
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P120009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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 Expiration Date: 08/31/2017
• Device Model Number: 145076V2
• Device Catalogue Number: 145076V2
• Device Lot Number: 1014444.01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2016
• 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: 14 MO
• Patient Weight: 8