MAUDE Adverse Event Report: ABBOTT VASCULAR INC. ARMADA; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	B1100-080
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/09/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Patient brought to ir, accompanied by crna and rn, for an outpatient scheduled fistulogram with possible intervention.An angioplasty was attempted.The balloon used burst and became lodged in patient.After unsuccessful attempts were made to retrieve the balloon, the plan was for the patient to be taken to operating room to have balloon removed surgically.Patient was removed from procedure table and taken to post op.After consulting additional physicians, the decision was made to bring the patient back to ir for a different approach.The patient returned to ir accompanied by crna and rn.After changing the approach to femoral access, the balloon was retrieved using a snare.When questioning staff, it was noted that there were stents in the patient that might have snagged the balloon, however it is unclear what the root cause was.Unfortunately, due to the condition of the balloon, staff discarded the device post-op.There was no harm to the patient, and they were discharged same day.

• Brand Name: ARMADA
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside dr; santa clara CA 95054
• MDR Report Key: 9752980
• Report Number: 9752980
• Device Sequence Number: 19499129
• Product Code: LIT
• UDI-Device Identifier: 08717648154966
• UDI-Public: (01)08717648154966
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/20/2020
• Report Date (Section F): 01/20/2020

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 Model Number: B1100-080
• Device Catalogue Number: B1100-080
• Device Lot Number: 90725G1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/26/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 91
• Date Report Sent to FDA: 01/20/2020