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

Catalog Number	1013456-200
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/18/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a moderately calcified lesion in the superficial femoral artery (sfa).The 4.0x200mm armada 18 balloon catheter was advanced to the target lesion and inflated to nominal pressure when it was noted the proximal balloon marker was located inside the balloon working length, not on the shoulder where it should be.Although the balloon markers were slightly off, the balloon worked as intended.The same balloon was used to successfully complete the procedure.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.
Additional Manufacturer Narrative
Correction: manufacturing site.The product was not returned to abbott vascular for analysis.A review of the electronic lot history record (elhr), database review and similar incident query for this product were not performed since the lot number was not reported and the device and packaging were not returned for analysis.The investigation was unable to determine a conclusive cause for the balloon marker alignment issue.The return of the device may have further aided the analysis as the balloon to marker alignment would have been measured to assure accurate marker placement.Per product specification, the outer edge of the proximal markers must be within 0-12 millimeters distance relative to the proximal balloon shoulder when the system is inflated to nominal pressure.Additionally, there was no report of marker placement issues with the distal marker placement.Per the photo provided by the account, the proximal balloon marker appears to be within specification of product specification requirements, even though it appears to be away from the intended marker location.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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: 8782333
• Report Number: 2024168-2019-10039
• Device Sequence Number: 13914726
• Product Code: LIT
• UDI-Device Identifier: 08717648207020
• UDI-Public: 08717648207020
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 08/26/2019

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 Catalogue Number: 1013456-200
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/18/2019
• Supplement Date Received by Manufacturer: 08/01/2019
• Initial Report FDA Received Date: 07/11/2019
• Supplement Report FDA Received Date: 08/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Weight: 73