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

Model Number	APB-3-4-3D-ES
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis as it wad 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 report that the axium coil failed detach with the instant detacher (id).The detachment attempt with the id was made 4 times without success.Manual detachment was attempted 2 times, also without success.The coil was reported not to have been implanted.The coil was reported as been discarded at the site.This event occurred during the treatment of a unruptured, amorphous aneurysm.The blood flow and the anatomy were reported to be normal.No patient injury reported.The devices were prepared and used per the instructions for use (ifu).The ancillary devices were discarded at the site.

• Brand Name: AXIUM PRIME BRPL 3D
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• MDR Report Key: 8422986
• Report Number: 2029214-2019-00208
• Device Sequence Number: 11305435
• Product Code: KRD
• UDI-Device Identifier: 00847536021228
• UDI-Public: 00847536021228
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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 a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/19/2021
• Device Model Number: APB-3-4-3D-ES
• Device Lot Number: A743056
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2019
• 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