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

Catalog Number	1013466-040
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/02/2019
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 case circumstances.It is likely that the rupture occurred due to interaction with heavily calcified lesion.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Exemption number e2019001.
Event or Problem Description
It was reported that on (b)(6) 2019, a percutaneous intervention was performed on the superficial femoral artery (sfa), heavily calcified lesion.Upon the first inflation to 13 atmospheres, the armada dilatation catheter balloon burst.Reportedly, the patient is in fine condition and the procedure was completed.There were no adverse patient effects and there was no clinically significant delay.No additional information was provided regarding this issue.

• 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: 9227124
• Report Number: 2024168-2019-12877
• Device Sequence Number: 11352915
• Product Code: LIT
• UDI-Device Identifier: 08717648207952
• UDI-Public: 08717648207952
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K151317
• 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): 10/23/2019

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: 11/30/2022
• Device Catalogue Number: 1013466-040
• Device Lot Number: 9060641
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/03/2019
• Initial Report FDA Received Date: 10/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1