MAUDE Adverse Event Report: AV-TEMECULA-CT ARMADA 18 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Catalog Number 1013465-100

Device Problems Crack (1135); Inflation Problem (1310)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/10/2017

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 was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that an armada dilatation catheter was advanced to the superficial femoral artery lesion without issue.Balloon inflation was attempted; however, the balloon failed to inflate.A crack in the armada catheter hub was then observed without any reported leaking noted.The device was removed and another balloon catheter was used in replacement.There were no adverse patient effects and there was no clinically significant delay.There was no additional information provided regarding this issue.

Manufacturer Narrative

(b)(4).The device was returned for analysis and abbott vascular (av) confirmed the reported failure to inflate, as the device was leaking at the hub when pressurized.The leak was detected at the base of the strain relief tubing.A review of the complaint handling database found one similar incident from this lot for leaks at the strain relief.Av conducted a thorough root cause analysis and determined the issue may be related to manufacturing.The issue is being addressed per internal operating procedures.Av will continue to trend the performance of these devices.

• Brand Name: ARMADA 18 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): CLONMEL, IRELAND REG# 9616693; 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: 7038261
• MDR Text Key: 93210848
• Report Number: 2024168-2017-09041
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151317
• 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,Followup
• Report Date: 12/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 1013465-100
• Device Lot Number: 6113041
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/15/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2016
• 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