MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 35 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Catalog Number	B1050-120
Medical Device Problem Codes	Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2024
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.H6: device code: 2017 clarifier: incorrect prep.
Event or Problem Description
It was reported that the procedure was to treat a lesion in external iliac artery with heavy calcification and heavy tortuosity.The 5x120mm armada 35 balloon dilatation catheter (bdc) was advanced to the target lesion and the balloon was inflated; however, the balloon ruptured during the first inflation at 8 atmospheres (atm).Therefore, the bdc was removed from the patient.Another armada balloon was used to complete the procedure.It was noted that the device was not prepped outside the anatomy prior to use, there was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection was performed on the returned device.The reported balloon rupture was confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents and/or complaints from this lot.It was reported that the device was not prepared (air aspiration) outside the anatomy.It should be noted that the percutaneous transluminal angioplasty (pta) armada 35 / armada 35 ll, global, instruction for use (ifu), 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.The investigation determined the reported complaint appears to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.

• Brand Name: ARMADA 35 PTA CATHETER
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• 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: 18759631
• Report Number: 2024168-2024-02245
• Device Sequence Number: 17719280
• Product Code: LIT
• UDI-Device Identifier: 08717648154645
• UDI-Public: 08717648154645
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,Followup
• Report Date (Section B): 03/14/2024

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: 04/30/2026
• Device Catalogue Number: B1050-120
• Device Lot Number: 21128G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2024
• Supplement Date Received by Manufacturer: 03/07/2024
• Initial Report FDA Received Date: 02/22/2024
• Supplement Report FDA Received Date: 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2022
• 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: 6F SHEATH
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 68 KG