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

Model Number	145076V2
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Codes	Vessel Or Plaque, Device Embedded In (1204); Foreign Body In Patient (2687)
Date of Event	08/28/2017
Type of Reportable Event	Malfunction
Event or Problem Description
When the coil was extruded into the proximal descending aorta, the leading edge lodged itself into the aorta.It was extremely difficult to get out.During the process of attempting to remove it (using catheters from the arterial side to pry it away from the aorta, as well as pulling with a snare), there was premature release of the delivery system from the device.At that point, device was half within the catheter and half outside.Physician was able to snare it and pull it off the aorta, and subsequently pulled both the snare and delivery catheter back through the pda into the main pulmonary artery and then to the ivc where it could be dealt with better without risk of dangerous embolization.Once there within the ivc, physician was able to get a better hold with the snare and pulled it into the sheath.Some came through and then, while pulling, the coil broke in half.Physician was able to withdraw first half, and then re-snare the remaining half and remove it.Physician then placed the next size nit-occlud coil and extruded it into descending aorta.Upon pulling back into the ampulla, it easily pulled across the pda into the pulmonary artery despite having repeated an angiogram and appropriately sizing to the new diameter.Physician thinks having pulled the previous device all the way through with a second catheter and the snare, dilated the pda.Physician then removed the second nit-occlud coil, and replaced it with an amplatzer device.Patient (b)(6), measured ductus size (mm): aortic - 2, pulmonary - 5, length - 7.Procedure duration: 196 mins.Pda access: venous.A 5fr introducer sheath was used.Physician did not notice high resistance during forwarding of the system into the implantation catheter.Physician noticed high resistance during retrieval of the system into the implantation catheter.Curvature of implantation catheter in the vessel: mild.Physician did not notice a gap between pusher and coil prior to release.The number of revolutions the physician moved the rotation screw forward for release was not noted.Physician stated that the first angiogram (before the first device) the ductus measured as noted, so a 7x6 was used.An angiogram before attempting the second nit-occlud device showed a minimal diameter of 2.5 mm.Physician used a 9x6 for that and it pulled right through.

• Brand Name: NIT-OCCLUD PDA
• Common Device Name: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• Manufacturer (Section D): PFM MEDICAL INC.; 1815 aston ave; suite 160; carlsbad CA 92008
• MDR Report Key: 6938883
• Report Number: 2032582-2017-00004
• Device Sequence Number: 566963
• Product Code: MAE
• UDI-Device Identifier: 04042301159991
• UDI-Public: 04042301159991
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P120009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/10/2017

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 Expiration Date: 11/07/2019
• Device Model Number: 145076V2
• Device Catalogue Number: 145076V2
• Device Lot Number: 1020429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2017
• Initial Report FDA Received Date: 10/10/2017
• 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
• Patient Age: 3 MO
• Patient Weight: 4