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

Model Number 145096

Device Problem Use of Device Problem (1670)

Patient Problem No Information (3190)

Event Date 01/01/2018

Event Type  malfunction  

Manufacturer Narrative

The sample was provided and was used to conduct an investigation.The device history record (dhr) has been reviewed and showed no deviations.The coil, item 145096, was severely defom1ed proximally.Deformations of this kind often occur when a coil needs to be retrieved using a sling.The securing clip on the handle had not been pulled yet.Based on the user statements, the described error feature cannot be reconstructed.The systems are pushed 100% through the enclosed catheter during the test in production.No further similar complaints were reported to mepro in the past.Based on previous experience, insufficient rinsing cannot be ruled out.The complaint is not justified.

Event Description

The coil was released inside the patient.Doctor's report: "we tried with a coil and during configuration of the last two loops, is stuck in the catheter refusing to get out or to get back in the catheter we tried a lot until it's released in improper position which force to snare it and send the patient to surgery.".

• Brand Name: NIT-OCCLUD PDA
• Type of Device: PDA OCCLUDER
• Manufacturer (Section D): PFM MEDICAL MEPRO GMBH; am söterberg 4; nonnweiler-otzenhausen, saarland 66620 ; GM 66620
• Manufacturer (Section G): PFM MEDICAL MEPRO GMBH; am söterberg 4; nonnweiler-otzenhausen, saarland 66620 ; GM 66620
• Manufacturer Contact: troy taylor ; 1916 palomar oaks way; suite 150; carlsbad, CA 92008
• MDR Report Key: 8316344
• MDR Text Key: 135542607
• Report Number: 3005704822-2018-00002
• Device Sequence Number: 1
• Product Code: MAE
• UDI-Device Identifier: 04042301160010
• UDI-Public: 04042301160010
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: P120009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 145096
• Device Catalogue Number: 145096
• Device Lot Number: 1018320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention