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

Model Number	1013468-040
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned to abbott vascular for analysis.A review of the electronic lot history record (elhr) and similar incident query for this product was not performed since the lot number was not reported and the product was not returned for analysis.The investigation determined the reported balloon rupture appears to be related to operational circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the heavily calcified superficial femoral artery.Standard pre-dilatation and post-dilatation were performed, along with laser atherectomy.A 5x40mm armada 18 percutaneous transluminal angioplasty (pta) balloon ruptured at 4 atmospheres.An unspecified balloon 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 OTW
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10498043
• Report Number: 2024168-2020-07428
• Device Sequence Number: 14216837
• Product Code: LIT
• UDI-Device Identifier: 08717648208171
• UDI-Public: 08717648208171
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/05/2020

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 Model Number: 1013468-040
• Device Catalogue Number: 1013468-040
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/19/2020
• Initial Report FDA Received Date: 09/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR