MAUDE Adverse Event Report: PFM MEDICAL MEPRO GMBH NIT-OCCLUD PDA; PDA OCCLUDER

Model Number 145076

Device Problems Fracture (1260); Material Separation (1562); Activation, Positioning or Separation Problem (2906)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); No Known Impact Or Consequence To Patient (2692)

Event Date 09/11/2019

Event Type  Injury  

Manufacturer Narrative

There was no effect on the patient.It cannot be excluded that a product defect exists.

Event Description

The proximal loop of the coil was fractured positioning the device on the defect.The device was placed on the defect.It was not necessary to remove it.Removing it could have led to complications due to the dimensions of the patient.There was a potential risk of embolization.This even occured in argentina using a product that is similarto one marketed in the us (ref (b)(4)).

Event Description

The device did not take the correct form, so it was removed to reposition.At the time of repositioning, it is released into the coronary artery.It was removed with the use of a multi-snare.Device is not marketed in the us but is similar to a us marketed device.

Manufacturer Narrative

The device history record (dhr) has been reviewed and showed no deviations.The information provided by the user was used to conduct an investigation.The following points were examined during the investigation: delivery condition.Completeness.Investigation of the present product regarding the described error characteristic further tests on a defect model with a coil of the same size were performed to simulate the described defect feature.The described error image could not be recreated.In summary, it was found that no deviations could be detected when checking device history record and the product itself.The product conforms to the specifications.

• Brand Name: NIT-OCCLUD PDA
• Type of Device: PDA OCCLUDER
• Manufacturer (Section D): PFM MEDICAL MEPRO GMBH; am söterberg 4; 66620 nonnweiler-otzenhausen; köln, nordrhein-westfalen 50996 ; GM 50996
• MDR Report Key: 8367488
• MDR Text Key: 139183601
• Report Number: 3005704822-2019-00001
• Device Sequence Number: 1
• Product Code: MAE
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/19/2021
• Device Model Number: 145076
• Device Catalogue Number: 145076
• Device Lot Number: 1024081
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention