MAUDE Adverse Event Report: PFM MEDICAL MEPRO GMBH NIT-OCCLUD PDA; OCCLUDER, PATENT DUCTUS, ARTERIOSUS

Model Number 145065V1

Device Problems Device Dislodged or Dislocated (2923); Premature Separation (4045)

Patient Problem Failure of Implant (1924)

Event Date 11/09/2022

Event Type  malfunction  

Event Description

Pediatric patient is admitted for percutaneous pda closure.An additional procedure is required to rescue the coil device, which released spontaneously and uncontrolled.The patient diagnosed with pda was treated by dr.(b)(6).She chooses a nit-occlud coil 6x5.When she was preparing the device, it presented resistance when advancing it through the sheath, (included with the device).At the time when the device is positioned in place, (at pda), the device spontaneously releases, and it is required to rescue, (snare), the device.The coil 6x5 is recovered with a snare.A pda 7x6 was implanted without complications.

Manufacturer Narrative

The complaint was forwarded to the manufacturer and investigated.The device history record (dhr) has been reviewed and showed no deviations.The information provided was used to conduct an investigation.During the investigation, severe deformations were found on the pusher unit and the coil.After consultation, the deformation on the pusher unit was explained by cleaning it by the hospital staff and thus occurred after use.The deformation on the coil could be explained with the described recovery with the snare.Furthermore, during the inspection the coil could be screwed to the carrier system again and showed no abnormalities.No cause could be found why the coil spontaneously releases early.

• Brand Name: NIT-OCCLUD PDA
• Type of Device: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• Manufacturer (Section D): PFM MEDICAL MEPRO GMBH; am soterberg 4; 66620 nonnweiler-otzenhausen, ; GM
• Manufacturer (Section G): PFM MEDICAL MEPRO GMBH; am soterberg 4; 66620 nonnweiler-otzenhausen, ; GM
• Manufacturer Contact: troy taylor ; 1916 palomar oaks; suite 150; carlsbad, CA 92008 ; 7607588749
• MDR Report Key: 16495516
• MDR Text Key: 310826236
• Report Number: 3005704822-2023-00001
• Device Sequence Number: 1
• Product Code: MAE
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: P120009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 145065V1
• Device Catalogue Number: 145065V1
• Device Lot Number: 1035001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2022
• Is the Device Single Use?: 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