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

Model Number	145116
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 145116, was still mounted on the carrier and with the proximal part still in the transportation sheath.The catheter was contaminated with blood and no longer usable.If the catheter has not been flushed enough during implantation, a graft may form which then makes the reason for the complaint plausible.To reconstruct the reason for the complaint, a new implantation catheter was used.The coil could be easily pushed through the catheter, configured, and withdrawn without problems.No further similar complaints were reported to mepro in the past.Based on previous experience, insufficient rinsing cannot be ruled out.The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 went out of the transportation sheath.Doctor's report: "after introducing the coil, we tried to reposition it.At the first trial of reposition the loops stucked on the catheter and refused to go back inside the catheter or refigured again at all.After flushing the system several times, we tried to pull it harder to let it move, then it's went out of the transportation sheath." could result in embolism of the device is occurred again required intervention to remove the device.

• 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: 8316341
• Report Number: 3005704822-2018-00001
• Device Sequence Number: 2284197
• Product Code: MAE
• UDI-Device Identifier: 04042301160034
• UDI-Public: 04042301160034
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 145116
• Device Catalogue Number: 145116
• Device Lot Number: 1021317
• 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: Other