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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT ARMADA 14 PTA CATHETER PERIPHERAL DILATATION CATHETER

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AV-TEMECULA-CT ARMADA 14 PTA CATHETER PERIPHERAL DILATATION CATHETER Back to Search Results
Catalog Number A2040-120
Device Problems Detachment Of Device Component (1104); Deflation Problem (1149); Difficult to Remove (1528)
Patient Problem Foreign Body In Patient (2687)
Event Date 05/16/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The device was received. The investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. Attachment: (b)(4).
 
Event Description
It was reported that the procedure was to treat a lesion located in the chronic occlusion of the left iliac vein. After advancement of the guide wire across the lesion, the 4. 0 x 120 mm armada 14 balloon dilatation catheter was advanced on the guide wire. After successful dilatation was performed, the balloon could not be deflated; however, was eventually able to be deflated. Sometime after deflation, it was observed that the balloon and tip had separated from the catheter. An attempt was made to snare the guide wire and the balloon catheter tip; however, this failed. The tip of the guide wire and the balloon and tip of the balloon catheter remain in the patient. Additionally, the user facility medwatch received states: patient had an ultrasound guided access left lower extremity popliteal vein balloon angioplasty. A retained 014 balloon tip and retained wire noted in left femoral vein; this occurred due to inability to remove balloon with deflation and other deflating maneuvers; wire sheared at popliteal access most likely due to multiple attempts to advance sheath over the wire to attempt new access and remove/snare 014 wire. No additional information was provided.
 
Manufacturer Narrative
(b)(4). Evaluation summary: visual inspections was performed on the returned device. The reported separations were confirmed. The reported deflation issue was unable to be confirmed due to the returned condition of the device. The reported difficulty to remove from the anatomy was unable to be replicated in a testing environment as it was based on operational circumstances. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. The investigation was unable to determine a conclusive cause for the reported deflation issue as there was minimal information provided. The reported/noted device separations and subsequent damaged appear to be related to circumstances of the procedure as it is likely that manipulation and/or mishandling of the device during deflation and retraction against resistance resulted in the reported/noted device, guide wire separations and inner/outer member damages ultimately causing the guide wire to become frozen in the guide wire lumen and the difficulty to remove. There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
 
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Brand NameARMADA 14 PTA CATHETER
Type of DevicePERIPHERAL 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 Key7641908
MDR Text Key112493390
Report Number2024168-2018-05072
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K102705
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 08/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2021
Device Catalogue NumberA2040-120
Device Lot Number7121241
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer06/20/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/15/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/27/2018 Patient Sequence Number: 1
Treatment
GUIDE WIRE: ASAHI ASTATO 30
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