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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 B2070-040
Device Problems Detachment Of Device Component (1104); Difficult to Remove (1528); Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/08/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). Evaluation summary: visual analysis was performed on the returned device. The reported balloon rupture and separation were confirmed. The difficulty to remove was not tested due to the condition of the device. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. Additionally, a review of the complaint history identified no other similar incidents from this lot. The investigation determined that the reported difficulties and subsequent treatment was due to case circumstances. There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
 
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 received. The investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.
 
Event Description
It was reported that the procedure was to treat a lesion in the heavily calcified iliac artery. A 7. 0 x 40 mm armada 35 percutaneous transluminal angioplasty (pta) catheter was advanced to the lesion with no resistance felt. The balloon ruptured at the 5th inflation of the balloon at 10 atmospheres, at contact with the atheroma plaque. The pta catheter could not be retracted through the guiding catheter and the distal shaft of the pta catheter separated. A cut down procedure was performed at the humeral artery to extract the distal shaft of the pta catheter. A new unspecified balloon catheter was used to successfully complete the procedure. 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 Key7072034
MDR Text Key109564959
Report Number2024168-2017-09280
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeFR
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 01/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/30/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2020
Device Catalogue NumberB2070-040
Device Lot Number61125G1
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer11/27/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/04/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2016
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: 11/30/2017 Patient Sequence Number: 1
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