MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 35 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Model Number	B1100-080
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Event date is estimated.The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no other complaints.Based on the information provided, the reported balloon rupture was likely due to circumstances of the procedure.It is likely that the difficulty advancing, and balloon rupture were the result of interaction with the previously placed stents.Additionally, it is likely that during removal, the ruptured balloon material caught on the introducer sheath, resulting in difficulty removing and separation of the balloon.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Attachment: medsun report number: 2300200000-2020-8002.
Event or Problem Description
User facility medwatch report received that states: "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 balloon, the plan was for the patient to be taken to or 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 the 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." no additional information was provided.
Additional Manufacturer Narrative
This report is being resubmitted to ensure the enclosed attachment can be easily opened by the fda.

• Brand Name: ARMADA 35 PTA CATHETER
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9897277
• Report Number: 2024168-2020-03067
• Device Sequence Number: 2333851
• Product Code: LIT
• UDI-Device Identifier: 08717648154966
• UDI-Public: 08717648154966
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K111899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: B1100-080
• Device Catalogue Number: B1100-080
• Device Lot Number: 90725G1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/05/2020
• Supplement Date Received by Manufacturer: 07/20/2020
• Initial Report FDA Received Date: 03/30/2020
• Supplement Report FDA Received Date: 07/29/2020
• 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: 78 YR
• Patient Weight: 91