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

Catalog Number	A1020-120
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/08/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device was not returned for analysis.In this case, it is likely that the rupture occurred due to interaction with the lesion which was described as a chronic total occluded de novo lesion with heavy calcification.It is likely that the calcification caused damage to the outer surface of the balloon.It should be noted that the armada 14 percutaneous transluminal angioplasty (pta) balloon catheter instructions for use states to prepare the catheter prior to insertion into the patient.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 incidents.Based on the information provided, the reported difficulties appear to be due to operational circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported the procedure was to treat a chronic total occluded de novo lesion with heavy calcification in the mid anterior tibial artery.The 2.0x120mm armada 14 balloon catheter was not prepped outside the anatomy prior to use.The catheter was advanced to the target lesion without resistance; however, loss of gauge pressure was noted.The balloon had ruptured at 10 atmosphere (atm) during the 1st inflation.A new 2.0x120mm armada 14 balloon catheter was used in the procedure successfully.There was no adverse patient effect.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: 6238874
• Report Number: 2024168-2017-00278
• Device Sequence Number: 16385608
• Product Code: LIT
• UDI-Device Identifier: 08717648155703
• UDI-Public: (01)08717648155703(17)190930(10)6040541
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K102705
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/10/2017

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: 09/30/2019
• Device Catalogue Number: A1020-120
• Device Lot Number: 6040541
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2016
• Initial Report FDA Received Date: 01/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1