MAUDE Adverse Event Report: ABBOTT VASCULAR INC. ARMADA¿; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	A1020-120
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during the procedural preparation of a 2.0x120mm armada 18 balloon dilatation catheter (bdc) that the inner packaging of the device was noted to have a hole when removed from its package.Therefore, another bdc was used to continue the procedure.There was no patient involvement nor clinically significant delay in procedure reported.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Additional Manufacturer Narrative
The device was not returned for analysis.Production record and corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint history identified no other similar complaints from this lot.Based on the information provided, a definitive cause for the reported complaint could not be determined.Possible factors that may contribute to a sterility breach (hole/tear) in the packaging pouch, include but are not limited to manufacturing, storage environment, transportation method, and handling at the account.The product risk assessment identifies this as a foreseeable event; as such, design and manufacturing controls and mitigations have been established for potential causes.In this case, a conclusive cause for the reported complaint could not be determined since the device was not retuned for analysis.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.D9 correction: device available for evaluation updated from yes to no.
Event or Problem Description
Subsequent to the initially filed reports it should be noted that the device is an armada 14.No additional information was provided.
Additional Manufacturer Narrative
B5: describe event or problem: revised.D9: corrected device available for evaluation from no to yes.Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Additional Manufacturer Narrative
Visual inspection was performed on the returned device.The reported complaint was confirmed.Production record and corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint history identified no other similar complaints from this lot.Based on the reported information and the observations from the returned analysis, a definitive cause for the reported complaint could not be determined.Possible factors that may contribute to a sterility breach (hole/tear) in the packaging pouch, include but are not limited to storage environment, transportation method, and handling at the account.In this case, a conclusive cause for the reported complaint could not be determined.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.H6: correction component code 4755 was removed h6: correction type of investigation code 4114 was removed h6: correction investigation findings code 3221 was removed h11: additional manufacturer narrative: revised.

• Brand Name: ARMADA¿
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary UNK ; EI UNK
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 22197256
• Report Number: 2024168-2025-06093
• Device Sequence Number: 21139119
• Product Code: LIT
• UDI-Device Identifier: 08717648155703
• UDI-Public: (01)08717648155703(11)240221(17)270731(10)4022141
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K102705
• 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,Followup,Followup,Followup
• Report Date (Section B): 12/18/2025

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 Model Number: A1020-120
• Device Catalogue Number: A1020-120
• Device Lot Number: 4022141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2025
• Supplement Date Received by Manufacturer: 08/28/2025; 11/05/2025; 12/05/2025
• Initial Report FDA Received Date: 06/12/2025
• Supplement Report FDA Received Date: 09/16/2025; 11/13/2025; 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2024
• 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
• Patient Sex: Unknown