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

Catalog Number F2020-020

Device Problems Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/19/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Use after expiration.Indication for use.The customer reported the device was discarded.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

It was reported that a 2.0x20mm armada 14 otw balloon catheter was used after expiration.The date of expiration is (b)(6) 2015; however, the balloon catheter was used on (b)(6) 2018.It was further reported that this device had been sent as a demo device.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was not returned 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 from this lot.It should be noted that he armada 14xt instructions for use states: note the use by date specified on the package.The investigation determined the reported complaint was due to user error.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

Subsequent to the previously filed report, additional information was received: the expired 2.0x20mm armada 14 otw balloon dilatation catheter (bdc) was being used to treat a stenosis in the infrapopliteal (below the knee).The bdc was used without issue to successfully complete the procedure.No additional information was provided.

• Brand Name: ARMADA 14 XT PTA CATHETER
• Type of Device: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 7789880
• MDR Text Key: 117432980
• Report Number: 2024168-2018-06301
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• PMA/PMN Number: K102705
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2015
• Device Catalogue Number: F2020-020
• Device Lot Number: 21219G1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1