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

Model Number	B1120-040
Medical Device Problem Codes	Off-Label Use (1494); Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a mildly calcified mid cephalic vein.The 12x40mm armada 35 balloon was inflated to nominal pressure; however, it was attempted to inflate again to rate burst pressure (rbp), but the balloon ruptured at an unknown pressure before reaching the rbp.The balloon ruptured radially and was partly stuck to the sheath; therefore, the devices were removed together.No other device was used.The initial inflation to nominal pressure opened up the stenosis and helped with the blood flow.There were no adverse patient effects reported and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.(b)(4).
Additional Manufacturer Narrative
Visual analysis was performed on the returned device.The reported balloon rupture and separation were confirmed.The difficulty removing was not tested due to the condition of the device.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 revealed no other incidents and/or complaints reported from this lot.It should be noted that the armada 35 instruction for use states: ¿the device is intended for dilatation of lesions in the renal, iliac, femoral, popliteal, tibial, and peroneal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.¿ it could not be determined if using the armada 35 off-label to treat the mid cephalic vein caused or contributed to the rupture.The investigation determined that the reported difficulties were likely due to circumstances of the procedure.It is likely that the balloon rupture was the result of interaction with the anatomy calcification.There were no leaks reported during preparation and the balloon had been previously inflated to nominal pressure successfully, suggesting that the damage was not pre-existing.In addition, the resistance noted during removal and radial separation of the balloon material was likely the result of the ruptured balloon material catching on the introducer sheath or anatomy during removal.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 to treat a mildly calcified mid cephalic vein.The 12x40mm armada 35 balloon was inflated to nominal pressure; however, it was attempted to inflate again to rate burst pressure (rbp), but the balloon ruptured at an unknown pressure before reaching the rbp.The balloon ruptured radially and was partly stuck to the sheath; therefore, the devices were removed together.No other device was used.The initial inflation to nominal pressure opened up the stenosis and helped with the blood flow.There were no adverse patient effects reported and no clinically significant delay in the procedure.Subsequently, to the initial being filed the account confirmed the device separated; however, the separated tip was attached to the wire when the balloon was removed.

• 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: 12839951
• Report Number: 2024168-2021-10602
• Device Sequence Number: 4638858
• Product Code: LIT
• UDI-Device Identifier: 08717648154980
• UDI-Public: 08717648154980
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2022

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: 11/30/2023
• Device Model Number: B1120-040
• Device Catalogue Number: B1120-040
• Device Lot Number: 00604G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/01/2021
• Supplement Date Received by Manufacturer: 01/21/2022
• Initial Report FDA Received Date: 11/18/2021
• Supplement Report FDA Received Date: 02/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2020
• 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