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

Catalog Number 1013470-200

Device Problems Break (1069); Leak/Splash (1354); Loose or Intermittent Connection (1371); Physical Property Issue (3008)

Patient Problem No Patient Involvement (2645)

Event Date 03/16/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was received.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

Reportedly, while attempting to prepare a 6x200mm armada 18 percutaneous transluminal angioplasty (pta) catheter a negative was pulled; however, it was noticed that the hub was leaking (bubbles were noticed).The indeflator was disconnected from the device and the device was inspected.It was noticed that the hub was not formed correctly/broken; which didn't allow the devices to connect properly.The device was not used and the procedure was successfully completed with a new 6x200mm armada 18 pta.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.Although, initial testing of the returned device indicated that the balloon fully inflated to nominal pressure of 8 atmospheres without any leaks observed, additional testing was done and a leak was noted coming from the distal end of the hub at 6 atmospheres.

Manufacturer Narrative

(b)(4).Evaluation summary: abbott vascular (av) analyzed the returned device and confirmed the reported leak in the distal end of the hub.A review of the complaint handling database found one similar incident from this lot.Av reviewed the lot history record and there were no manufacturing nonconformities that would have contributed to this complaint.Av conducted root cause determined the most probable root cause is variability in the gluing process during manufacturing.The issue will be 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: 6488960
• MDR Text Key: 72936576
• Report Number: 2024168-2017-03115
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08717648208461
• UDI-Public: (01)08717648208461(17)200229(10)6091541
• 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: 05/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: 1013470-200
• Device Lot Number: 6091541
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/22/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2016
• 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