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

Model Number	145076V2
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/21/2016
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.It was reported that the system was not controlled prior to the application - whether the coil was connected to the carrier.No high resistance was noted when the coil was advanced.After the coil was in a good position it released itself without actuating the dropping.The coil was stable and the shunt decreased after 12 minutes.The complaint was confirmed by the accompanying video.The investigation of the carrier system could not provide information about the reason for the complaint.The gap was with 4 mm within the specification, as well as the discharge part of the carrier.The safety split pin was still mounted.A corrective action for the error identification and correction will be initiated.This complaint is justified.
Event or Problem Description
Physician reported an awful premature release.Physician forgot to check that the device was attached to the cable, when the pda coil (last loop) was deployed, the device released.It did release in a good position, was stable, and the shunt diminished to trivial with resolution of the murmur in 12 minutes.The physician did not notice high resistance during forwarding of the system into the implantation catheter.Physician did not notice a gap between pusher and coil prior to release.If issue recurred it could lead to embolization of the device.

• 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: 8313090
• Report Number: 2032582-2016-00013
• Device Sequence Number: 11294347
• Product Code: MAE
• UDI-Device Identifier: 04042301159991
• UDI-Public: 04042301159991
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P120009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• 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: 145076V2
• Device Catalogue Number: 145076V2
• Device Lot Number: 1014640.01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2016
• 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