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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 1014263-180
Device Problems Inflation Problem (1310); Physical Property Issue (3008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/07/2017
Event Type  malfunction  
Manufacturer Narrative
Internal file number (b)(4). Evaluation summary: visual and functional inspections were performed on the returned device. The inflation issue and irregular appearance were not confirmed. 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 of the reported lot revealed no other incidents. The investigation determined that the reported difficulties were due to operational context and there is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.
 
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The device was received. Investigation is not yet complete. A follow up report will be submitted with all relevant information. The other armada device referenced is filed under separate a medwatch report.
 
Event Description
It was reported that the patient underwent a procedure, treating a target lesion in the left superficial femoral artery (sfa). The lesion was pre-dilated. A 5. 0 x 200 mm supera stent was implanted and a 5. 0 x 180 mm armada 18 dilatation catheter was advanced for post-dilatation. The balloon was inflated; however, it was noted that the mid portion of the balloon did not inflate and the balloon had a waist. The device was removed and a second 5. 0 x 180 mm armada 18 dilatation catheter was advanced to the site and the balloon was inflated. This device also did not inflate in the mid portion of the balloon. The balloons seemed to be twisted around the shaft in the mid portion and not able to open at that particular spot. The physician was able to use the armada 18 dilatation catheters for post-dilatation and there was no adverse patient effect. There was no clinically significant delay. 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 Key6679838
MDR Text Key246486903
Report Number2024168-2017-05542
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K151317
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 08/23/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2017
Device Catalogue Number1014263-180
Device Lot Number5070741
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer06/29/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/16/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2015
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: 06/29/2017 Patient Sequence Number: 1
Treatment
SHEATH: 6 FRENCH,SUPERA STENT.
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