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

Model Number	F2015-020
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.The additional device referenced in b5 is filed under separate medwatch report number.
Event or Problem Description
It was reported that the procedure was to treat an occlusion in the right peroneal artery.The 1.5x20mm armada balloon dilatation catheter (bdc) was used in the procedure with the ht command es 300cm guide wire (gw); however, the bdc and the gw became stuck together during removal.Therefore, the bdc and the gw had to be removed as a single unit.There was no adverse patient effect reported and no clinically significant delay reported in the procedure.A new bdc and gw were used to successfully complete the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual analysis was performed on the returned device.The reported difficulty was confirmed.The balloon catheter was separated at the mid lap seal.The inner member was stretched at the noted separation.Follow up was performed with the account and they confirmed that the separation was not noted during the procedure.In this case, it is possible that the separation and stretching occurred during removal and/or manipulation of the device during packaging to return the device to abbott vascular; however, a conclusive cause cannot be determined.Based on the information reported through the complaint report, a conclusive cause for the reported difficulty removing the device from the guide wire could not be determined.Possible factors that may contribute to the difficult removing the guide wire causing resistance between the devices may include, but not limited to, manufacturing damage, inner diameter of guide wire lumen, condition of the guide wire, or damage to the distal shaft of the catheter.The production record and corrective and preventive actions (capa) review was 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.There is no indication of a product quality issue with respect to manufacture, design or labeling.D1 correction: brand name updated d2a correction: common device name updated d3 correction: name, address updated.
Event or Problem Description
Subsequent to the report being filed return device analysis found the balloon catheter was separated at the mid lap seal.No additional information was provided.

• 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 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: 19383425
• Report Number: 2024168-2024-06235
• Device Sequence Number: 6341709
• Product Code: LIT
• UDI-Device Identifier: 08717648182884
• UDI-Public: (01)08717648182884(17)260731(10)30812G1
• 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,Followup
• Report Date (Section B): 07/10/2024
• 2 Devices were Involved in the Event: 1 2

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: 07/31/2026
• Device Model Number: F2015-020
• Device Catalogue Number: F2015-020
• Device Lot Number: 30812G1
• 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: 05/06/2024
• Supplement Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 05/23/2024
• Supplement Report FDA Received Date: 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: COMMAND GUIDE WIRE
• Patient Sex: Male