MAUDE Adverse Event Report: ABBOTT VASCULAR INC. ARMADA; PERIPHERAL DILATATION CATHETER

Model Number	A1030-060
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during preparation of the 3.0x60mm armada 14 balloon dilatation catheter, it was noted the balloon was perforated.Another armada balloon catheter was used to complete the procedure.There was no clinically significant delay in the procedure and no patient involvement.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
Visual and functional analysis was performed on the returned device.The reported tear in the balloon was not confirmed; however, a pinhole rupture was noted on the returned device, which is likely what the account perceived as the reported complaint.The production record and corrective and preventive 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 results of the complaint investigation there is no indication the reported tear in the balloon or noted pinhole rupture on the returned device is related to a potential product quality issue.Possible factors that could contribute to a balloon tear and/or material ruptures include, but are not limited to, balloon damage during processing of the balloon material, handling damage, inflation technique and insufficient preparation.Return device analysis noted a pinhole like rupture/tear in the balloon material.In this case, it is possible that the balloon became damaged during sheath removal and/or during preparation such that a pinhole like rupture/tear occurred; however, a conclusive cause cannot be determined since limited information was provided.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: ARMADA
• Common Device Name: PERIPHERAL DILATATION CATHETER
• 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 ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 19631851
• Report Number: 2024168-2024-07784
• Device Sequence Number: 15227262
• Product Code: DQY
• UDI-Device Identifier: 08717648155802
• UDI-Public: (01)08717648155802(17)261031(10)3050941
• 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
• Report Date (Section B): 08/27/2024

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: A1030-060
• Device Catalogue Number: A1030-060
• Device Lot Number: 3050941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/13/2024
• Supplement Date Received by Manufacturer: 08/07/2024
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2023
• 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