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

Catalog Number B1050-020

Device Problems Inflation Problem (1310); Leak/Splash (1354); Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/13/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The device is expected to be returned for evaluation. It has not yet been received. A follow up report will be submitted with all relevant information.

Event Description

It was reported that this was a percutaneous intervention, treating a de novo lesion within an arterial-venous shunt. During use of the armada dilatation catheter, contrast was observed leaking from the base of the catheter shaft. Another armada was used in replacement. There were no adverse patient effects and there was no clinically significant delay. No additional information was provided regarding this issue.

• 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: 8224240
• MDR Text Key: 132345262
• Report Number: 2024168-2019-00143
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K111899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/11/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 07/31/2019
• Device Catalogue Number: B1050-020
• Device Lot Number: 60225G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial