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

Model Number	1013470-040
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat the calcified superficial femoral artery (sfa).The 6x40 mm armada 35 pta catheter ruptured during the first inflation at 8 atm.The 6x40 mm armada 18 percutaneous transluminal angioplasty (pta) catheter ruptured during the first inflation at 6 atmospheres (atm).There were no adverse patient effects and no clinically significant delay in the procedure.Returned device analysis of the armada 18 pta catheter identified that the balloon inner member and tip and markers were separated from the device and not returned.The account was not aware of the separation.There is the potential that some material remained in the patient.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.The additional device referenced in b5 is filed under a separate medwatch report number.
Additional Manufacturer Narrative
A visual and dimensional inspection was performed on the returned device.The reported material rupture was confirmed.A review of the production records and the corrective and preventive actions (capa) database was performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed no indication of a lot specific issue.The investigation was unable to determine a conclusive cause for the reported material rupture or patient effect.It was reported that the balloon dilatation catheter¿s (bdc) balloon ruptured during inflation analysis of the returned device confirmed the reported material rupture as a radial balloon rupture.Additionally, the inner member and balloon was noted to be separated.This type of damage is consistent with manipulation against resistance.It is possible that handling during the procedure contributed to balloon damage, resulting in the rupture and subsequent separation; however, this cannot be confirmed.The user stated they were unaware of the separation; therefore, it is unknown if material was left in the anatomy.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Event or Problem Description
Returned device analysis of the armada 18 pta catheter identified that the balloon inner member and tip and markers were separated from the device and not returned.The account was not aware of the separation.There is the potential that some material remained in the patient.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, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 20184452
• Report Number: 2024168-2024-10620
• Device Sequence Number: 18318990
• Product Code: LIT
• UDI-Device Identifier: 08717648208393
• UDI-Public: (01)08717648208393(17)270131(10)3080341
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K151317
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1013470-040
• Device Catalogue Number: 1013470-040
• Device Lot Number: 3080341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/20/2024
• Supplement Date Received by Manufacturer: 09/23/2024
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown