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

Catalog Number B2050-060

Device Problems Deflation Problem (1149); Difficult to Remove (1528); Folded (2630)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/29/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was returned for analysis and abbott vascular (av) confirmed the reported difficulty in deflating the balloon.A review of the complaint handling database found no similar incidents from this lot.Av conducted a thorough root cause analysis and determined the deflation issue is potentially related to manufacturing.The issue is being addressed per internal operating procedures.Av will continue to trend the performance of these devices.

Event Description

It was reported that the patient underwent a peripheral procedure, treating a target lesion in the right iliac artery.The armada 35 dilatation catheter was advanced to the target lesion and was inflated 1 time, to 18 atmospheres (atm) and deflated without issue.The device was inflated a second time, to 18 atm, but deflated slowly.Difficulty was noted removing the device, and upon removal, the balloon was noted to have bunched up towards the tip of the device.A second unspecified dilatation catheter was used, and was followed by stenting.There was no adverse patient effect and no 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: 7216017
• MDR Text Key: 98412974
• Report Number: 2024168-2018-00557
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08717648155185
• UDI-Public: 08717648155185
• 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: 01/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: B2050-060
• Device Lot Number: 60331G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2016
• 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
• Patient Age: 77 YR
• Patient Weight: 73