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

Catalog Number	B2060-200
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a lesion in the right superficial femoral artery (sfa) with mild calcification and no tortuosity.The 6.0x200mm armada 35 balloon dilatation catheter (bdc) was advanced without resistance and inflated multiple times with the 1st inflation at 4 atmospheres (atms) for 10 sec, 2nd inflation at 12 atms for 30 sec, 3rd inflation at 12 atms for 30 sec, 4th inflation at 8 atms for 30 sec, 5th inflation 22 atms for 30 sec, 5th inflation 30 atms for 15 second at which time the balloon ruptured.Blood was leaking in the balloon therefore the balloon was attempted to be removed from the anatomy, however, the balloon bunched up in the sheath and the balloon got stuck.Force was applied and the balloon separated.About 150mm of the balloon was left in the anatomy.An attempt to snare the separated portion was unsuccessful so the patient was sent to surgery and a femoral exploration was performed able to remove the entire balloon from the anatomy.A femoral popliteal bypass was also performed.The patient is stable.There was no adverse patient sequelae.There was no delay in the procedure that resulted in the patient going into surgery.No additional information was provided.
Additional Manufacturer Narrative
H6: medical device problem code 2017 - above rbp / excessive force.The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no other complaints reported from this lot.It was reported that the armada 35 balloon dilatation catheter (bdc) was inflated up to 30 atmospheres for 15 seconds at which time the balloon ruptured.The armada 35 instructions for use (ifu), states: ¿inflation in excess of the rated burst pressure may cause the balloon to rupture.It should be noted that the rated burst pressure for this device as indicated on the product label is 14 atmospheres.It is likely that inflating the balloon two-times the rated burst pressure caused the balloon to rupture.Additionally, it was reported that after the balloon ruptured, the balloon bunched up in the sheath and the balloon got stuck.Force was applied and the balloon separated.About 150mm of the balloon was left in the anatomy.Although it was reported that extra force was used to remove the balloon catheter, the excess force seemed to be a reasonable clinical response to the difficulties encountered.The balloon rupture and subsequent treatment appear to be the result of inflating the balloon above the rated burst pressure.Based on the information provided, the reported balloon rupture resulting in difficulty removing, material separation, and unexpected medical intervention to surgically remove the separated material appears to be the result of inflating the balloon above the rated burst pressure.Additionally, the resistance encountered during removal and material separation likely occurred due to the ruptured balloon material catching on the sheath.There is no indication of a product quality issue with respect 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: 17482568
• Report Number: 2024168-2023-08534
• Device Sequence Number: 7144727
• Product Code: LIT
• UDI-Device Identifier: 08717648155321
• UDI-Public: 08717648155321
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 08/08/2023

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: 09/30/2026
• Device Catalogue Number: B2060-200
• Device Lot Number: 30405G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/21/2023
• Initial Report FDA Received Date: 08/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 6FR 45CM INTRODUCER SHEATH
• Outcome Attributed to Adverse Event: Required Intervention; Disability
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 78 KG