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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT ARMADA 18 PTA CATHETER PERIPHERAL DILATATION CATHETER

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AV-TEMECULA-CT ARMADA 18 PTA CATHETER PERIPHERAL DILATATION CATHETER Back to Search Results
Catalog Number 1013465-100
Device Problems Device Difficult to Setup or Prepare (1487); Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/17/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. Evaluation summary: visual and functional inspection was performed on the returned device. The reported failure to flush was confirmed due to a pinhole in the balloon. It is likely that the balloon rupture is the result of interaction with anatomy or associated devices causing damage to the outer surface of the balloon. 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 revealed no other incidents. The investigation determined the reported difficulties appear to be related to circumstances of the procedure. There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
 
Event Description
It was reported that the procedure was to treat a lesion in the anterior tibial artery. The 3. 0x100mmx150cm armada 18 balloon dilatation catheter (bdc) was advanced to the target lesion for pre-dilatation and was used without issue. The armada bdc was removed without issue, however when an attempt was made to flush the bdc to reuse it again, the armada bdc could not be flushed. Another bdc was used to complete the procedure. There were no adverse patient effects and no reported clinically significant delay in the procedure. Returned device analysis identified fluid was observed coming out from a pinhole in the balloon. No additional information was provided.
 
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Brand NameARMADA 18 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 Key7527072
MDR Text Key108807115
Report Number2024168-2018-03723
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K151317
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 05/18/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/18/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2021
Device Catalogue Number1013465-100
Device Lot Number7081441
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/03/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/08/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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