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

Model Number	1013470-100
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis.The lot history record (lhr) for this product could not be reviewed and a similar complaint query could not be performed because the product was not returned for evaluation and the lot number was not reported.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 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.The additional armada device is filed under separate medwatch report number.
Event or Problem Description
It was reported that the procedure was to treat a calcified superficial femoral artery (sfa).The armada 18 6x100 mm percutaneous translumnial angioplasty (pta) catheter ruptured after one inflation to nominal pressure.The device was removed and a new armada 18 6x150 mm pta catheter was used and again the balloon ruptured after one inflation at nominal pressure.An unspecified balloon was used to complete the procedure.There were no reported adverse patient effects and there was no reported 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: 12111684
• Report Number: 2024168-2021-05674
• Device Sequence Number: 4600660
• Product Code: LIT
• UDI-Device Identifier: 08717648208423
• UDI-Public: 08717648208423
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 07/02/2021

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: 1013470-100
• Device Catalogue Number: 1013470-100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/11/2021
• Initial Report FDA Received Date: 07/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1