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

Model Number	1013466-200
Medical Device Problem Codes	Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device code: (b)(4).A visual and functional analysis was performed on the returned device.The reported balloon rupture was confirmed.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 18 instruction for use states: inflation in excess of the rated burst pressure may cause the balloon to rupture.Use of a pressure monitoring device is recommended.It could not be determined if inflating the balloon slightly over the rated burst pressure solely caused the rupture.The investigation determined that the reported balloon rupture was likely due to case related circumstances.It is likely that the rupture occurred due to interaction with lesion calcification or associated devices.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The additional armada 14 device is being filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was to treat a right tibial artery.A 4x200mm armada 18 balloon was advanced to the lesion and inflated once at 18 atmospheres (atms) when it ruptured.Another 4x60mm armada 14 balloon was then used but when inflated once it ruptured at about 4 atms.Another armada was used to successfully complete the procedure.There were no adverse patient effects and 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
• MDR Report Key: 12050954
• Report Number: 2024168-2021-05335
• Device Sequence Number: 3428542
• Product Code: LIT
• UDI-Device Identifier: 08717648208027
• UDI-Public: 08717648208027
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/23/2021

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: 03/31/2023
• Device Model Number: 1013466-200
• Device Catalogue Number: 1013466-200
• Device Lot Number: 9100141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 06/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 105