MAUDE Adverse Event Report: AV-TEMECULA-CT ARMADA 14 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Catalog Number	A2030-200
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The product was not returned to abbott vascular for analysis.It should be noted that the armada 14 pta catheter instructions for use (ifu) states: 1000 /500 cc heparinized normal saline / 60% contrast diluted 1:1 with normal saline to be used.In this case, it is likely the ifu deviation contributed to the reported difficulties of deflation issue.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 from this lot.The investigation determined the reported deflation issue appears to be related to the user error as 100% contrast was used in 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 the procedure was performed to treat a lesion with heavy calcification in the distal posterior tibial artery.The armada 14 balloon catheter was advanced to the target lesion successfully.During inflation, the physician could not see the balloon very well; therefore, contrast was changed to 100% for visibility.The balloon was inflated multiple times successfully to 10 atmospheres.However, during deflation the balloon had difficulties deflating and took a long time to deflate.The balloon eventually deflated completely and was removed without issue.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: ARMADA 14 PTA CATHETER
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 7511683
• Report Number: 2024168-2018-03548
• Device Sequence Number: 1523612
• Product Code: LIT
• UDI-Device Identifier: 08717648156113
• UDI-Public: 08717648156113
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K102705
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/14/2018

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: 04/30/2021
• Device Catalogue Number: A2030-200
• Device Lot Number: 7111441
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2018
• Initial Report FDA Received Date: 05/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Weight: 119