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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 1014256-120
Device Problems Difficult To Position (1467); Difficult to Remove (1528); Stretched (1601)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/15/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device is expected to be returned for evaluation.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 to treat a superficial femoral artery.As a 5.0 x 120 mm armada 18 was being advanced over the guide wire there was some resistance felt, however, the balloon was able to be placed in the lesion.When removing the balloon catheter and attempting to re-introduce over the guide wire there was strong resistance.It was noticed that the inner member was elongated into a curve shape inside the balloon and the wire could not be advanced through the inner member.Another same size balloon was successfully used to complete the procedure.There was no clinically significant delay in procedure and no adverse patient effects.No additional information was provided.
 
Manufacturer Narrative
(b)(4).Evaluation summary: visual, dimensional and functional inspections were performed on the returned device.The reported resistance with the guide wire and elongation of the inner member were confirmed.The investigation determined the reported resistance with the guide wire and elongation of the inner member appears to be related to circumstances of the procedure.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other incidents from this lot.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.
 
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Brand Name
ARMADA 18 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)
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 Key6223359
MDR Text Key64058869
Report Number2024168-2017-00076
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K151317
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Health Professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 02/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/30/2019
Device Catalogue Number1014256-120
Device Lot Number6040441
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/10/2017
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/15/2016
Initial Date FDA Received01/04/2017
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received02/06/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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