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

Model Number	1013470-200
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned to abbott vascular for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents and/or complaints reported from this lot.The device was prepped prior to use with no issue/ leak noted, which would suggest that the device was not damaged prior to use.The investigation determined the reported balloon rupture appears to be related to operational circumstances of the procedure.Based on the reported information, it is likely that advancement through the anatomy and/or other devices used, the balloon became compromised or damaged resulting in the reported balloon rupture.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 6.0x200 mm armada 18 balloon dilatation catheter was properly prepared outside the patient without issue.The armada 18 was advanced to the left superficial femoral artery and inflated to ten atmospheres, but the armada ruptured with the first inflation.The armada was removed in one piece without resistance.A same size non-abbott balloon dilatation catheter was used to complete the procedure without further incident.There were no adverse patient effects and no clinically significant delay in the procedure.There was no additional information 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: 10065262
• Report Number: 2024168-2020-04346
• Device Sequence Number: 16310114
• Product Code: LIT
• UDI-Device Identifier: 08717648208461
• UDI-Public: 08717648208461
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 05/18/2020

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: 05/31/2023
• Device Model Number: 1013470-200
• Device Catalogue Number: 1013470-200
• Device Lot Number: 9121341
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2020
• Initial Report FDA Received Date: 05/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 65