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

Catalog Number B2050-020

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint device was not returned for investigation.A search of the complaint handling database was performed and no other incidents were identified from this lot for this issue.Based on an expanded investigation, however, a product issue related to leakage at the hub/luer was identified.The probable cause was identified as a lack of concentricity between the luer and the shaft which creates a narrow space between them.This results in restriction for the adhesive to flow evenly, creating a weak bond in the assembly.Corrective and preventive actions to address this issue have been implemented.The performance of these devices will continue to be monitored.

Event Description

It was reported that the procedure was to treat an eccentric, de novo lesion in the common iliac artery that was mildly tortuous and mildly calcified, with (b)(6) stenosis.A 5.0x20mm armada 35 percutaneous transluminal angioplasty (pta) catheter was prepped without issue and advanced to the lesion where inflation was attempted.The balloon was inflated for 30 seconds, however, pressure could not be raised higher than 8 atmospheres.Contrast appeared to drip from the guide wire lumen, although it could not be confirmed exactly where the leak was.There was no blood observed in the leaked contrast.The procedure was successfully completed with another new same-sized armada 35 pta catheter.There was no adverse patient effect and no clinically significant delay in the procedure.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: 5323423
• MDR Text Key: 34920534
• Report Number: 2024168-2015-07964
• 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,distri
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: B2050-020
• Device Lot Number: 41121G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2015
• Initial Date FDA Received: 12/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2014
• 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