MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 14 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Catalog Number	A2030-080
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a lesion located in an unspecified vessel.The 3.0x80 mm armada 14 and 2.0x120 mm armada 14 balloon dilatation catheters (bdc) were prepared without issue.The 3x80 mm armada bdc was advanced to the lesion and inflated, however it ruptured at 6 atmospheres during the third inflation.The balloon was removed without issue.The 2x120 mm armada bdc was then advanced to the lesion and inflated; however, it also ruptured at 6 atmospheres during the second inflation.The balloon was removed without issue.A 0.9 laser and mini trek balloon were used to complete the procedure.There were no reported adverse patient effects and no clinically significant delays in the procedure.No additional information was provided.
Additional Manufacturer Narrative
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 identified no other similar incidents and/or complaints from this lot.The investigation was unable to determine a conclusive cause for the reported balloon rupture.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.The additional armada 14 device referenced in b5 is filed under separate medwatch report number.

• Brand Name: ARMADA 14 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: 18610321
• Report Number: 2024168-2024-01224
• Device Sequence Number: 12639724
• Product Code: DQY
• UDI-Device Identifier: 08717648156090
• UDI-Public: 08717648156090
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K102705
• 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): 01/30/2024

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 Catalogue Number: A2030-080
• Device Lot Number: 3073141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/05/2024
• Initial Report FDA Received Date: 01/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2023
• 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
• Patient Age: 66 YR
• Patient Sex: Male