MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 18 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Model Number	1013470-150
Medical Device Problem Codes	Failure to Fold (1255); Inflation Problem (1310); Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exemption number e2019001.The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the mildly calcified superficial femoral artery with a flux occlusion.A 5.5x150mm and two 5.5x100mm supera self-expanding stents were implanted without any issues.A 6x150mm armada 18 percutaneous transluminal angioplasty (pta) balloon was advanced without resistance, but during the first inflation at 6 atmospheres (atms), the middle portion of the balloon did not fully inflate until the third inflation at the same pressure.The pta balloon was now fully inflated, and post-dilatation was complete.The balloon deflated, but the balloon did not refold tightly.During removal, the balloon felt resistance with the introducer sheath, and the pta catheter was removed with the non-abbott sheath as a single unit.A new sheath was advanced for confirmation imaging.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual analysis was performed on the return device with the outer member separated.The reported inflation issue, difficulty removing were unable to be confirmed due to the condition of the returned unit.The balloon was wrinkled confirming the refold issue.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents and/or complaints from this lot.Based on the information provided, the reported difficulties appear to be due to case related circumstances.It is likely that the lesion prevented the balloon from fully expanding in the middle portion.Additionally, it is likely that the balloon material became compromised during the inflation attempts resulting in poor refold and causing resistance during removal due to interaction with the introducer sheath.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
Subsequent to the initially filed report, the following information was received: returned device analysis identified a separation in the outer member, but this was not noted during the procedure.The device likely separated during return packaging or shipment.It was confirmed that no portion of the device remains in the patient anatomy.No additional information was provided.

• Brand Name: ARMADA 18 PTA CATHETER
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9305061
• Report Number: 2024168-2019-13419
• Device Sequence Number: 19298800
• Product Code: LIT
• UDI-Device Identifier: 08717648208447
• UDI-Public: 08717648208447
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K151317
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2020

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: 11/30/2022
• Device Model Number: 1013470-150
• Device Catalogue Number: 1013470-150
• Device Lot Number: 9060741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2019
• Initial Date Received by Manufacturer: 10/24/2019
• Supplement Date Received by Manufacturer: 01/27/2020
• Initial Report FDA Received Date: 11/11/2019
• Supplement Report FDA Received Date: 02/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 87