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

Model Number	F2020-020
Medical Device Problem Codes	Stretched (1601); Failure to Advance (2524); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual inspection was performed on the returned device.The reported failure to advance and difficulty advancing the device were confirmed.Additionally, the inner member and shaft on the returned device was noted to be stretched.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.The investigation was unable to determine a conclusive cause for the reported failure to advance, difficulty advancing the device or the noted stretched inner member and shaft.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.Estimated date of event: (b)(6) 2023.The additional guidewire device is filed under separate medwatch report number.
Event or Problem Description
It was reported that on the back table, during prep, a command guide wire was attempted to be advanced through the 2x20 mm armada 14 percutaneous transluminal angioplasty (pta) catheter but there was resistance.There may have been a blockage in the lumen of the balloon or the lumen was bent.There was no reported device use or patient involvement and there was no reported clinically significant delay in the procedure.A new balloon was used to complete the procedure with the same command guide wire.Returned device analysis identified that a potentially abbott guide wire was returned frozen in the lumen of the armada pta catheter.The proximal end of the balloon was wrinkled and the inner member was stretched then bunched at same location.No additional information was provided.

• 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
• Manufacturer (Section G): ABBOTT VASCULAR COSTA RICA, REG # 3009564766; 52 calle 3 b31 coyol free zone; el coyol alajuela ; CS
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 16420303
• Report Number: 2024168-2023-01782
• Device Sequence Number: 6384892
• Product Code: LOX
• UDI-Device Identifier: 08717648182938
• UDI-Public: 08717648182938
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K121352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/22/2023

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: 01/31/2025
• Device Model Number: F2020-020
• Device Catalogue Number: F2020-020
• Device Lot Number: 20204G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/01/2023
• Initial Report FDA Received Date: 02/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN AV GUIDE WIRE
• Patient Sex: Unknown