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

Model Number	B2050-120
Medical Device Problem Codes	Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device was not returned for analysis.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 of the reported lot revealed no other complaints.The armada 35 instruction for use states: inflation in excess of the rated burst pressure may cause the balloon to rupture.Based on the information provided, the balloon rupture was the result of procedural circumstances.It could not be determined if the balloon rupture was the result of interaction with the heavy lesion calcification, or if inflating the balloon above the rated burst pressure of 18 atmospheres caused the rupture.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 heavily calcified superficial femoral artery.An 5.0x120mm armada 35 balloon was prepped per the instructions for use (ifu) with no issues.The balloon ruptured at the third inflation at 21 atmospheres, previous two inflation's were reported as nominal inflations.It was noted the physician was aware of inflating device above rated burst pressure (rbp).A new unspecified balloon was used to successfully complete procedure.There was no adverse patient effects and no clinically significant delay.No additional information was provided.

• Brand Name: ARMADA 35 PTA CATHETER
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9763914
• Report Number: 2024168-2020-01834
• Device Sequence Number: 713633
• Product Code: LIT
• UDI-Device Identifier: 08717648155215
• UDI-Public: 08717648155215
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K111899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/27/2020

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: 04/30/2022
• Device Model Number: B2050-120
• Device Catalogue Number: B2050-120
• Device Lot Number: 81116G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2020
• Initial Report FDA Received Date: 02/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 90