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

Model Number	B2060-040
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2024
Type of Reportable Event	Malfunction
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
Visual and functional analysis were performed on the returned device.The reported balloon rupture was confirmed.The production record and corrective and preventive actions (capa) reviews were 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 investigation determined the reported balloon rupture appear to be related to operational context.There was no leak noted during preparation, which suggests a product quality issue did not contribute to the reported difficulty.In this case, it is likely that the balloon interacted with the moderately calcified anatomy such that the balloon became damaged (scratched) and subsequently ruptured during inflation.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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 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: 20182815
• Report Number: 2024168-2024-10619
• Device Sequence Number: 20898196
• Product Code: LIT
• UDI-Device Identifier: 08717648155260
• UDI-Public: (01)08717648155260(17)270930(10)40422G1
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K111899
• 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): 09/12/2024

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 Model Number: B2060-040
• Device Catalogue Number: B2060-040
• Device Lot Number: 40422G1
• 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): Follow-Up
• Initial Date Received by Manufacturer: 08/20/2024
• Supplement Date Received by Manufacturer: 09/11/2024
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 09/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/22/2024
• 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