MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 18 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Model Number	1013468-200
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot number was not provided.The investigation determined the reported balloon rupture appears to be related to operational context.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.The additional armada 18 and armada 14 devices referenced are being filed under separate medwatch report numbers.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the superficial femoral artery (sfa) with moderate calcification and no tortuosity and anterior tibial artery with moderate calcification and no tortuosity.The 5.0x120mm armada 18 balloon dilatation catheter (bdc) advanced without any resistance noted and ruptured at nominal pressure during the first inflation.Another 5.0x200mm armada 18 (bdc) was then advance without resistance noted as well, however, ruptured during the first inflation at 14 atmospheres (atms).The balloon pressure was held for about 2 minutes and at about 1.5 minutes it ruptured.The 2.0x200mm armada 14 bdc wad advanced to the anterior tibial artery without resistance but also ruptured at nominal pressure during the first inflation.Again, the pressure was held for 2 minutes but this time ruptured after about a minute.All devices were prepared per instructions for use (ifu).Non-abbott balloons were used to complete the procedure for the sfa and the anterior tibial artery.There was no adverse patient effect and there was no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: ARMADA 18 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, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 15676054
• Report Number: 2024168-2022-11062
• Device Sequence Number: 20425342
• Product Code: LIT
• UDI-Device Identifier: 08717648208249
• UDI-Public: 08717648208249
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K151317
• 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): 10/26/2022

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 Model Number: 1013468-200
• Device Catalogue Number: 1013468-200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/21/2022
• Initial Report FDA Received Date: 10/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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