MAUDE Adverse Event Report: AV-TEMECULA-CT ARMADA 35 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Catalog Number B2060-020

Device Problems Crack (1135); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/15/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation summary: visual and functional inspections were performed on the returned device.The crack and leak were not confirmed.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 of the reported lot revealed no other incidents.The investigation was unable to determine a conclusive cause for the reported issue.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

It was reported that the procedure was to treat a heavily calcified, de novo lesion in the non-tortuous left iliac artery.After prepping a 6.0mm x 20mm x 135cm armada 35 balloon dilatation catheter (bdc) without issue, with negative pressure drawn using an indeflator inflation device, it was advanced toward the lesion without resistance.Prior to reaching the lesion, it was noted that the bdc was unable to hold the negative pressure.While there was no issue with connection and no blood was noted in the hub area of the device (no leak in fluid path), air bubbles and a possible crack were noted at the hub connection luer of the armada.The armada bdc was withdrawn from the anatomy without difficulty and dilatation was completed successfully with the same indeflator and a new unspecified balloon.There were no adverse patient effects and no occurrence of a clinically significant delay.No additional information was provided.

• Brand Name: ARMADA 35 PTA CATHETER
• Type of Device: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): EL COYOL, COSTA RICA REG# 3009031392; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 6380657
• MDR Text Key: 69368477
• Report Number: 2024168-2017-01838
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08717648155253
• UDI-Public: (01)08717648155253(17)180331(10)41002G1
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Catalogue Number: B2060-020
• Device Lot Number: 41002G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: INFLATION: INDEFLATOR
• Patient Age: 72 YR
• Patient Weight: 79