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

Model Number	B1080-060
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	01/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the 8.00x60mm armada 35 balloon dilatation catheter (bdc) was prepped per instructions for use (ifu).The procedure was to treat a lesion in the left av fistula.The bdc was advanced to the target lesion and the balloon was inflated 2 times to 18 atmospheres (atm); however, during the second inflation the balloon ruptured transversely.The bdc was removed from the patient, with fragments of the balloon remaining in the patient.Another bdc was advanced past the balloon fragments.The balloon was then inflated trapping the fragments so that the fragments could be snared out of the patient.There was no adverse patient sequela and no clinically significant delay was reported.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).The device was not returned for evaluation.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 of the reported lot did not indicate a lot specific quality issue.It was reported that the balloon was inflated to 18 atmospheres two times and then the balloon ruptured.It should be noted that the armada 35 / armada 35 ll instruction for use (ifu) states: ¿inflation in excess of the rated burst pressure may cause the balloon to rupture.Use of a pressure monitoring device is recommended.¿ the rated burst pressure for this device is 14 atmospheres as indicated on the product label.Based on the reported information, it is likely that the ifu deviation contributed to the reported balloon rupture.The investigation determined the reported balloon rupture appears to be related to user error; however, the reported removal of foreign body and unexpected medical intervention appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respects to the 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: 16288022
• Report Number: 2024168-2023-01122
• Device Sequence Number: 6475347
• Product Code: LIT
• UDI-Device Identifier: 08717648154874
• UDI-Public: 08717648154874
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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): 02/02/2023

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: 03/31/2026
• Device Model Number: B1080-060
• Device Catalogue Number: B1080-060
• Device Lot Number: 21004G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/11/2023
• Initial Report FDA Received Date: 02/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 83 KG