MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 14 XT PTA CATHETER; PERIPHERAL DILATATION CATHETER

Catalog Number	F2020-020
Medical Device Problem Codes	Inflation Problem (1310); Product Quality Problem (1506); Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G9: exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.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 to treat the radial cephalic artery.The armada 14 percutaneous transluminal angioplasty (pta) catheter was inflated twice to 14 atmospheres (atm) and would only partially inflate.The device was holding pressure and the balloon would not fully inflate.Additionally, the proximal end of the balloon appeared elongated.Another armada 14 pta catheter was used to complete the procedure.There were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.Returned device analysis identified a stretched shaft.
Additional Manufacturer Narrative
Exemption number e2019001 permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.Visual and functional analysis was performed on the returned device.The reported inflation issue and balloon elongation was unable to be confirmed.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 incidents and/or complaints.The investigation was unable to determine a cause for the reported inflation issue and appearance of balloon elongation.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: ARMADA 14 XT PTA CATHETER
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 8898857
• Report Number: 2024168-2019-10896
• Device Sequence Number: 1413317
• Product Code: LOX
• UDI-Device Identifier: 08717648182938
• UDI-Public: 08717648182938
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K121352
• 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,Followup
• Report Date (Section B): 09/16/2019

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 Expiration Date: 02/28/2021
• Device Catalogue Number: F2020-020
• Device Lot Number: 80301G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2019
• Initial Date Received by Manufacturer: 07/24/2019
• Supplement Date Received by Manufacturer: 09/06/2019
• Initial Report FDA Received Date: 08/15/2019
• Supplement Report FDA Received Date: 09/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1