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

Catalog Number	A2030-120
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2023
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.Na.
Event or Problem Description
It was reported that the procedure was to treat a mildly calcified anterior tibial artery.The 3.0x120mm armada 14 balloon dilatation catheter (bdc) was inflated to 8 atmospheres, however, a leak was noted on the delivery system at the hub.A new 3.0x200mm armada 14 was used to successfully complete the procedure.There was no adverse patient effects reported and no clinically significant delay reported.No additional information was provided.
Additional Manufacturer Narrative
Visual, functional and scanning electron microscopy (sem) inspections/analysis were performed on the returned device.The reported leak was confirmed.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 incidents/complaints from this lot.A cine was received and reviewed by an abbott vascular clinical specialist.The complaint summary states that a 3.0 x 120 mm armada 14 balloon dilatation catheter was inflated to 8 atmospheres and a leak was noted on the delivery system hub.The provided media (video) confirms the reported event as a continuous dripping of contrast/saline can be seen from the proximal end of the armada 14 catheter where the hypotube meets the proximal connector hub.The media also shows the indeflator cannot maintain a constant pressure as a result of the fluid leak during balloon inflation.The investigation determined the noted leak and possible gap/channel in the adhesive at the distal bonding point 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.

• Brand Name: ARMADA 14 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, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 17703263
• Report Number: 2024168-2023-09736
• Device Sequence Number: 6719106
• Product Code: DQY
• UDI-Device Identifier: 08717648156106
• UDI-Public: 08717648156106
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2023

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: 09/30/2025
• Device Catalogue Number: A2030-120
• Device Lot Number: 2042241
• 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: 08/15/2023
• Supplement Date Received by Manufacturer: 10/26/2023
• Initial Report FDA Received Date: 09/07/2023
• Supplement Report FDA Received Date: 10/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2022
• 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
• Patient Sex: Unknown