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

Model Number	B1080-060
Medical Device Problem Codes	Material Rupture (1546); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a 60% stenosed vessel in the left arteriovenous (av) fistula.The 8.0x60mm armada percutaneous transluminal angioplasty (pta) catheter was soaked prior to use and was prepared (air aspiration) outside the anatomy prior to use without any issues.However, the armada balloon was inflated once with a pressure of 17 atmospheres (atms) and ruptured.It was noted that the radiopaque marker came off the balloon when it ruptured.The sheath was already in the anatomy and the radiopaque marker was able to be removed on the sheath.There was no resistance during advancement or withdrawal.Another armada 35 was used to complete the procedure.There was no adverse patient effect and there was minimal delay in the procedure; however, there was no impact to the patient.No additional information was provided.
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
B5 correction: it was reported that the procedure was to treat a 60% stenosed vessel involving an arteriovenous (av) dialysis fistula in the left arm.No additional information was provided.
Additional Manufacturer Narrative
Medical device problem code: 2017 - use above rated burst pressure visual inspection was performed on the returned device.The reported balloon rupture and separation were confirmed.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 identified no other similar incidents and/or complaints from this lot.The investigation determined the reported balloon rupture appears to be related to user error; however, the reported separation appears to be related to circumstance of the procedure.It was reported that the 8.0x60mm armada balloon catheter was inflated above the rated burst pressure (rbp), to 17 atmospheres (atm) when the balloon ruptured.It should be noted that the percutaneous transluminal angioplasty (pta), armada 35 / armada 35 ll, global, instructions for use (ifu) states: inflation in excess of the rated burst pressure may cause the balloon to rupture.The rbp for the armada 35device is 14 atm.In this case, it is likely the ifu deviation resulted in the reported balloon rupture.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.B5: correction.

• 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: 13500178
• Report Number: 2024168-2022-01352
• Device Sequence Number: 20171841
• Product Code: LIT
• UDI-Device Identifier: 08717648154874
• UDI-Public: 08717648154874
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 03/14/2022

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: B1080-060
• Device Catalogue Number: B1080-060
• Device Lot Number: 00611G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2022
• Supplement Date Received by Manufacturer: 02/23/2022
• Initial Report FDA Received Date: 02/09/2022
• Supplement Report FDA Received Date: 03/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2020
• 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