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

Model Number	B2070-100
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/24/2025
Type of Reportable Event	Serious Injury
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, separation, unexpected medical intervention, surgical intervention, delay in the procedure, and hospitalization appear to be related to operational context.A conclusive cause for the reported patient effect of hemorrhage/blood loss/bleeding and the relationship to the device, if any, cannot be determined.The reported patient effect of hemorrhage/blood loss/bleeding is listed in the percutaneous transluminal angioplasty (pta) catheter, armada 35 / armada 35 ll, global, instruction for use as a known patient effect.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 introducer sheath 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.
Event or Problem Description
It was reported that the procedure was treat a lesion in the right external iliac artery.Two supera stents, 6.0x150mm and 5.5x150mm, were implanted in the left superficial femoral artery (sfa) without issues.The 7.0x100mm armada 35 balloon dilatation catheter (bdc) was used for pre-dilatation of the right external iliac artery and an 8.0x100mm unspecified stent was implanted.The same armada balloon was used for post dilatation approximately four times, at 14 atmospheres (atms); however, the balloon ruptured.An attempt was made to remove the bdc but it became stuck while being pulled through the sheath, and separated.Multiple attempts were made to remove the separated portion of the balloon with a snare and support catheter but were unsuccessful.It was noted that there was some extended bleeding around the sheath of the left radial artery.Surgical cutdown and endarterectomy were performed and nothing remains in the patient.A clinically significant delay in the procedure was noted and the patient will remain hospitalized for multiple days.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: 21423443
• Report Number: 2024168-2025-01903
• Device Sequence Number: 12809327
• Product Code: LIT
• UDI-Device Identifier: 08717648155383
• UDI-Public: (01)08717648155383(17)271031(10)40515G2
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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
• Report Date (Section B): 02/20/2025

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: B2070-100
• Device Catalogue Number: B2070-100
• Device Lot Number: 40515G2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/15/2024
• 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: Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 79 KG