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

Model Number	B2050-150
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.D4: the udi is not known as the part and lot number were not provided.H6: medical device problem code 2017 clarifier- incorrect prep.
Event or Problem Description
It was reported that the procedure was to treat the superficial femoral artery (sfa) with mild calcification, moderate tortuosity and 80% stenosis.The 5x150 mm armada 35 percutaneous transluminal angioplasty (pta) catheter was not prepped (air aspirated) prior to use.The device was attempted to be inflated but failed and a leak at the hub was noted.Another balloon was used to complete the procedure.There were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection, functional testing, and sem analysis were performed on the returned device.The reported leak and inflation issue were confirmed.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 reported information and the observations from the returned analysis, a definitive cause for the reported leak and inflation issue could not be determined.Sem analysis determined the leakage at the proximal end of the luer, at the guidewire port, may be attributed to mechanical damage.Mechanical damage was documented at the leak edges along with possible damage (or a crease) at the edge of the inflation lumen opening.In this case, it is possible that the noted damage resulted from interaction with the guide wire during loading and/or inadvertent manipulation of the guide wire in the device; however, a conclusive cause cannot be determined.It was reported that the device was not prepared (air aspiration).It should be noted that the percutaneous transluminal angioplasty (pta) armada 35 / armada 35 ll, global, instruction for use indicates to perform the steps to remove all air and verify the integrity of the pta catheter.Leave the catheter under negative pressure until the balloon is at the target lesion site.Then the device can be introduced the device into the vascular system.In this case, it is unknown if the violation of the ifu caused or contributed to the reported complaint.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.D4: catalog number updated from unk armada to b2050-150.D4: lot number updated from unknown to 30202g1.D4: primary udi number corrected from unk to (b)(4).

• 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: 19986420
• Report Number: 2024168-2024-09578
• Device Sequence Number: 7164374
• Product Code: LIT
• UDI-Device Identifier: 08717648155222
• UDI-Public: (01)08717648155222(17)260731(10)30202G1
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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
• Report Date (Section B): 12/10/2024

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 Expiration Date: 07/31/2026
• Device Model Number: B2050-150
• Device Catalogue Number: B2050-150
• Device Lot Number: 30202G1
• 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: 07/23/2024
• Supplement Date Received by Manufacturer: 12/06/2024
• Initial Report FDA Received Date: 08/14/2024
• Supplement Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2023
• 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
• Patient Sex: Unknown