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

Model Number	B1070-060
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.H6: medical device problem code 2017 - excessive force.
Event or Problem Description
It was reported that the procedure was performed to treat the proximal superficial femoral artery with heavy calcification and mild tortuosity.The 7x60mm armada 35 balloon percutaneous transluminal angioplasty catheter which was prepared per instructions for use, was advanced and the balloon was inflated once to below rated burst pressure.After 2 minutes of inflation, the pressure dropped and a rupture was noted.Upon withdrawal of the dilatation catheter, resistance was noted and force was applied.The balloon separated and only the proximal portion was withdrawn.The unspecified 6fr introducer sheath was exchanged for a larger unspecified 8fr sheath, and an unsuccessful attempt was made to snare the distal portion.A surgical cut down procedure was performed and the distal portion was successfully retrieved.There was no adverse patient sequela.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.Production record and corrective and preventative 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.Based on the information received, the investigation determined that the reported balloon rupture, difficulty removing the device, unexpected medical intervention and surgical procedure appear to be related to operational context; however, the reported separation appears to be related to use error/operational context.There was no leak noted during preparation, which suggests a product quality issue did not contribute to the reported difficulties.In this case, it is likely that the balloon interacted with the heavily calcified anatomy such that the balloon became damaged and ruptured.In addition, the ruptured balloon material likely interacted with the patient anatomy and/or accessory devices during removal, resulting in the reported difficulty removing the device and upon further manipulation and applied force, the device ultimately separated.It was reported by the account that upon withdrawal of the dilatation catheter, resistance was noted, and force was applied.It should be noted that the percutaneous transluminal angioplasty catheter (pta), armada 35/ armada 35ll global, ce, instruction for use (ifu introduction and dilatation) states: maintaining a vacuum in the balloon, withdraw the catheter.Note: gentle counterclockwise twisting motion of the balloon may ease withdrawal through the sheath or from the percutaneous entry site.If the balloon cannot be withdrawn through the sheath, withdraw the catheter and sheath as one unit.In this case, the physician did not follow the instructions for use.Instead of using gentle counterclockwise twisting motion to remove the device, force was applied which likely contributed to the reported separation.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: 20997542
• Report Number: 2024168-2024-15218
• Device Sequence Number: 12464972
• Product Code: LIT
• UDI-Device Identifier: 08717648154799
• UDI-Public: (01)08717648154799(17)270630(10)40122G1
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2025

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: B1070-060
• Device Catalogue Number: B1070-060
• Device Lot Number: 40122G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2024
• Supplement Date Received by Manufacturer: 01/03/2025
• Initial Report FDA Received Date: 12/22/2024
• Supplement Report FDA Received Date: 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/22/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED 6FR INTRODUCER SHEATH.; UNSPECIFIED 8FR INTRODUCER SHEATH.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown