MAUDE Adverse Event Report: COVIDIEN (IRVINE) AXIUM PRIME BARE PL 3D; DEVICE, EMBOLIZATION, VASCULAR

Model Number	APB-1.5-2-3D-ES
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned as it was discarded at the site.Since the device was not returned, we are unable to perform further root cause analysis.All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that after the axium implant coil was detached with the instant detacher, the physician withdrew the pushwire into the microcatheter and saw that the implant coil was also moving back into the microcatheter.Then the physician attempted to retrieve the coil along with the microcatheter, but the coil was drawn back into the aneurysm somehow and the procedure was completed.No patient injury was reported as a result of the event.The instant detacher (id) was brand new.2 detachment attempts were made with the id.The proximal end of the pushwire was not damaged.The devices were all discarded at the site.The patient was undergoing embolization treatment of an aneurysm (distorted) measuring 4mm.

• Brand Name: AXIUM PRIME BARE PL 3D
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• MDR Report Key: 8420723
• Report Number: 2029214-2019-00200
• Device Sequence Number: 1795497
• Product Code: KRD
• UDI-Device Identifier: 00847536021143
• UDI-Public: 00847536021143
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K151447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/14/2019

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 Expiration Date: 01/17/2021
• Device Model Number: APB-1.5-2-3D-ES
• Device Lot Number: A583343
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2019
• Initial Report FDA Received Date: 03/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1