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

Model Number 145116

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 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complaint, a new implantation catheter was used.The coil could be easily pushed through the catheter, configured, and withdrawn without problems.No further similar complaints were reported to mepro in the past.Based on previous experience, insufficient rinsing cannot be ruled out.The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 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
• 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: 8316341
• MDR Text Key: 136873608
• Report Number: 3005704822-2018-00001
• Device Sequence Number: 1
• Product Code: MAE
• UDI-Device Identifier: 04042301160034
• UDI-Public: 04042301160034
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• 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): Other