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

Model Number	B1120-040
Medical Device Problem Codes	Off-Label Use (1494); Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562); Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was performed to treat a heavily calcified and mildly tortuous lesion in the pulmonary valve.A 12x40mm armada 35 balloon dilatation catheter (bdc) was used; however, the balloon was noted to rupture at 10atm during the first inflation.A strong resistance was noted during removal through the 7f guiding sheath, and the shaft of the bdc separated.The physician decided to perform surgery to remove the separated shaft, and the procedure was completed.There were no adverse patient effects and no clinically significant delay 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.
Event or Problem Description
It was reported that the procedure was performed to treat a heavily calcified and mildly tortuous lesion in the pulmonary valve.A 12x40mm armada 35 balloon dilatation catheter (bdc) was used; however, the balloon was noted to rupture at 10atm during the first inflation.A strong resistance was noted during removal through the 7f guiding sheath, and the shaft of the bdc separated.The physician decided to perform surgery to remove the separated shaft, and the procedure was completed.There were no adverse patient effects and no clinically significant delay in the procedure.Subsequent to the initially filed report, additional information was provided.The shaft was not separated, the balloon separated.Additionally the cuts noted to the balloon and inner member were due to the surgical removal of the device.The balloon was noted to be scratched when attempting to remove it through the sheath.No additional information was provided.
Additional Manufacturer Narrative
Visual analysis was performed on the returned device.The reported balloon rupture, separation and scratched material were confirmed.The reported difficulty removing the device could not be replicated in a testing environment due to the condition of the returned device.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.It was reported that the procedure was to treat a pulmonary valve.It should be noted percutaneous transluminal angioplasty catheter (pta), armada 35/armada 35ll, global, instruction for use, ifu, states: the device is intended for dilatation of lesions in the renal, iliac, femoral, popliteal, tibial, and peroneal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.In this case, it is unknown if the ifu violation contributed to the reported complaint.The investigation determined the reported balloon rupture, scratched material, difficulty removing the device, separation and surgical intervention 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 heavily calcified anatomy such that the balloon became damaged (scratched) and ruptured during inflation.Additionally, during removal there was resistance as the ruptured balloon material likely interacted with the guiding catheter causing the balloon material to separate.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Additional Manufacturer Narrative
H6: medical device problem code 1494 removed.H11: the following statement has been removed: it was reported that the procedure was to treat a pulmonary valve.It should be noted percutaneous transluminal angioplasty catheter (pta), armada 35/armada 35ll, global, instructions for use, ifu, states: the device is intended for dilatation of lesions in the renal, iliac, femoral, popliteal, tibial, and peroneal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.In this case, it is unknown if the ifu violation contributed to the reported complaint.

• 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: 20065151
• Report Number: 2024168-2024-09977
• Device Sequence Number: 20743110
• Product Code: LIT
• UDI-Device Identifier: 08717648154980
• UDI-Public: (01)08717648154980(17)270630(10)40131G1
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/19/2024

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: B1120-040
• Device Catalogue Number: B1120-040
• Device Lot Number: 40131G1
• 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: 08/07/2024
• Supplement Date Received by Manufacturer: 09/30/2024; 10/29/2024
• Initial Report FDA Received Date: 08/26/2024
• Supplement Report FDA Received Date: 10/18/2024; 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown