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

Model Number	145096
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/01/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: PDA OCCLUDER
• Manufacturer (Section D): PFM MEDICAL MEPRO GMBH; am söterberg 4; nonnweiler-otzenhausen, saarland 66620 ; GM 66620
• MDR Report Key: 8316344
• Report Number: 3005704822-2018-00002
• Device Sequence Number: 47062
• Product Code: MAE
• UDI-Device Identifier: 04042301160010
• UDI-Public: 04042301160010
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• 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): 02/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/07/2019
• 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: Required Intervention