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

Model Number	A2015-080
Medical Device Problem Codes	Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a moderately calcified, mildly tortuous, de novo lesion in the left anterior tibial artery.A 1.5x80mm armada 14 balloon dilatation catheter (bdc) ruptured during the first inflation to 24 atmospheres (atm).It is suspected that the rupture was due to the calcified lesion.There was no adverse patient effect and no clinically significant delay in the procedure.Another armada bdc was used to successfully complete the procedure.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
Visual inspection was performed on the returned device.The reported balloon rupture 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 similar incidents and/or complaints from this lot.The investigation determined the reported balloon rupture appears to be related to user error/operational context.The bdc was overinflated to 24 atmospheres (atms) when the balloon ruptured.It should be noted that the percutaneous transluminal angioplasty (pta), armada 14 xt, over the wire (ot), global instructions for use (ifu) states: balloon pressure should not exceed the rated burst pressure (rbp).The rated burst pressure for this device is 14 atmospheres as indicated on the product label.In this case, it is likely the combination of the ifu deviation, and the moderately calcified anatomy contributed to the reported event.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
Event or Problem Description
N/a.

• 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: 15331765
• Report Number: 2024168-2022-09299
• Device Sequence Number: 17752168
• Product Code: DQY
• UDI-Device Identifier: 08717648155925
• UDI-Public: 08717648155925
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 10/10/2022

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: 11/30/2024
• Device Model Number: A2015-080
• Device Catalogue Number: A2015-080
• Device Lot Number: 1062941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/11/2022
• Supplement Date Received by Manufacturer: 09/20/2022
• Initial Report FDA Received Date: 08/31/2022
• Supplement Report FDA Received Date: 10/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2021
• 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