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U.S. Department of Health and Human Services

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

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AV-TEMECULA-CT ARMADA 35 PTA CATHETER PERIPHERAL DILATATION CATHETER Back to Search Results
Catalog Number B2060-040
Device Problems Leak/Splash (1354); Difficult to Remove (1528); Material Separation (1562)
Patient Problem Vessel Or Plaque, Device Embedded In (1204)
Event Date 02/07/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. Concomitant medical products: guide wire: terumo advantage 0. 035. Stent: 8x80 covera, begraft. The device is expected to be returned for investigation. It has not yet been received. A follow-up report will be submitted with all additional relevant information.
 
Event Description
It was reported that the procedure was performed to treat a totally occluded lesion in the iliac artery. Following recanalization, a 6x40mm armada 35 balloon catheter was used to pre-dilate the lesion. An 8x80mm non-abbott covered stent failed to cross due to the bifurcation and was removed. The balloon catheter was re-advanced for additional pre-dilatation; however, after dilatation the balloon became stuck with the anatomy and was not able to move forward or backwards. It was noted that the balloon catheter became damaged because blood was noted in the lumen. A puncture on the other groin was made to advance the guide wire into an introducer sheath and remove the catheter from the other side, but the guide wire was also stuck in the balloon catheter. The guide wire was pulled very hard with forceps while the balloon catheter was held down. A jolt was felt and the resistance lessened. The balloon catheter and half of the balloon came out. The remaining part of the balloon stayed in the common iliac. Several attempts were made to snare the separated balloon portion, but were unsuccessful. The balloon was covered with a peripheral stent graft. The patient is doing well. No additional information was provided.
 
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Brand NameARMADA 35 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)
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 Key8401411
MDR Text Key138157071
Report Number2024168-2019-01791
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
K111899
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 04/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/07/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2022
Device Catalogue NumberB2060-040
Device Lot Number81019G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/28/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/12/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2018
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: 03/07/2019 Patient Sequence Number: 1
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