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

Model Number	B2060-060
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Based on the information provided, the reported balloon rupture appears to be due to circumstances of the procedure.It is likely that the rupture occurred due to interaction with the heavy lesion calcification causing damage to the outer surface of the balloon resulting in rupture during inflation.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
On hold for kd 3.16 it was reported that this was a procedure to treat a lesion in the superficial femoral artery.The armada balloon catheter was advanced to the lesion, but the balloon ruptured at unknown pressure.An unspecified balloon catheter was used successfully in the procedure.A supera stent was implanted successfully.There was no adverse patient effect and no clinically significant delay in the procedure.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: 11424231
• Report Number: 2024168-2021-01757
• Device Sequence Number: 4077130
• Product Code: LIT
• UDI-Device Identifier: 08717648155277
• UDI-Public: 08717648155277
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/05/2021

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 Model Number: B2060-060
• Device Catalogue Number: B2060-060
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/08/2021
• Initial Report FDA Received Date: 03/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1