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

Model Number	A1025-200
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to perform recanalization and percutaneous transluminal angioplasty (pta) of the lower left leg using the antegrade approach.Three armada balloon dilatation catheters (bdc) were attempted to be used in the procedure; however, two of the armada balloons failed to deflate properly and both were difficult to remove.After removal, the balloons were noted to be twisted.In the physician opinion the material of the pta balloons is weaker causing balloon twisting [torsion].A third armada bdc was attempted to be used in the procedure; however, the balloon was noted to have a leak at the hub.Another armada 14 balloon was used to complete the procedure.There was no adverse patient effect and no clinically significant delay reported in the procedure.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.D4 - a partial udi was provided as the lot number is not known.The additional vascular devices referenced in b5 are filed under separate medwatch report numbers.
Additional Manufacturer Narrative
Visual, functional and scanning electron microscopy (sem) analysis were performed on the returned device.The reported leak was confirmed.The production record 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.The leak was observed coming out of the distal end of the stain relief tubing.It was determined the device leakage from the distal end of the luer may possibly be attributed to a gap/channel in the adhesive at the distal bond area.The investigation determined the noted leak appears to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.D1 correction: brand name updated d2a correction: common device name updated d3 correction: name, address updated d4 correction: catalog number updated from unk armada to a1025-040 d4 correction: lot number updated from unknown to 3032841 d4 correction: primary udi number updated.

• 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: 19222994
• Report Number: 2024168-2024-05342
• Device Sequence Number: 18191309
• Product Code: DQY
• UDI-Device Identifier: 08717648155772
• UDI-Public: (01)08717648155772(17)260930(10)3040541
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2024

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 Expiration Date: 09/30/2026
• Device Model Number: A1025-200
• Device Catalogue Number: A1025-200
• Device Lot Number: 3040541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/10/2024
• Supplement Date Received by Manufacturer: 09/11/2024
• Initial Report FDA Received Date: 05/01/2024
• Supplement Report FDA Received Date: 09/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2023
• 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