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

Model Number	B1090-040
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2024
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.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the left subclavian vein with no calcification.The 9x40 mm armada 35 percutaneous transluminal angioplasty (pta) catheter was inflated once to 10 atmospheres and ruptured during use.The distal end of the balloon severed and was stuck in the arteriovenous fistula.The fistula was clamped and surgery was performed to remove the balloon as it could not be removed through the introducer sheath.The patient needed a bandage for 10 days and experienced a delay in their dialysis.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 provided, a definitive cause for the reported balloon rupture could not be determined; however, the reported difficulty removing the device, balloon separation, surgical intervention and delay to treatment/therapy appear to be related to circumstances of the procedure.Possible factors that could contribute to the reported balloon rupture, include, but are not limited to, balloon damage during processing of the balloon material, insufficient preparation, inflation technique, or inadvertently mishandled during preparation.In this case, a conclusive cause for the reported balloon rupture cannot be determined since the device was not retuned for analysis.Additionally, the ruptured balloon material likely interacted with the patient anatomy resulting in the reported difficulty removing the device and upon further manipulation, the balloon ultimately separated.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.B2: outcomes attributed to ae corrected from hospitalization-initial, required intervention prolonged to required intervention only.B5: describe event or problem: updated.
Event or Problem Description
Subsequent to the previously filed report, additional information was received: it was stated the procedure was a laparoscopic cut.The patient is fine.No additional information was provided.

• 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: 20970897
• Report Number: 2024168-2024-15011
• Device Sequence Number: 15565020
• Product Code: LIT
• UDI-Device Identifier: 08717648154904
• UDI-Public: (01)08717648154904(17)260630(10)30120G2
• Combination Product (Y/N): N
• Initial Reporter Country: RE
• 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: Pharmacist
• 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 Expiration Date: 06/30/2026
• Device Model Number: B1090-040
• Device Catalogue Number: B1090-040
• Device Lot Number: 30120G2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/10/2024
• Supplement Date Received by Manufacturer: 01/06/2025
• Initial Report FDA Received Date: 12/18/2024
• Supplement Report FDA Received Date: 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/20/2023
• 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: Required Intervention; Hospitalization
• Patient Sex: Unknown