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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 B1060-080
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 06/08/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). The device is expected to be returned for evaluation. It has not yet been received. A follow up report will be submitted with all relevant information.
 
Event Description
It was reported the procedure was to treat a lesion in the right superficial femoral artery (sfa). The 6. 0x80mm armada 35 balloon was inflated to 16 atmospheres (atm) when the balloon ruptured. During removal, the balloon became stuck with the distal tip of the 8fr sheath. Slight force was applied and the balloon separated. General anesthesia was administered and a cut down was performed, removing the sheath and separated balloon portion. There was a clinically significant delay in the procedure due to the device issue. No additional information was provided.
 
Manufacturer Narrative
(b)(4). A visual inspection was performed, and the reported balloon rupture and balloon separation were confirmed. The reported difficulty to remove was unable to be confirmed due to the returned 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 reported from this lot. The investigation determined the reported difficulties of balloon rupture, balloon separation, difficulty to remove, subsequent treatments and cut down to remove the distal end of the balloon, inner member separation and noted damages appear to be related to circumstances of the procedure, as it is likely that the balloon became compromised or damaged during advancement with the anatomy and/or with other devices used during the procedure, resulting in the reported balloon rupture during inflation at 16 atmospheres. During retraction, the ruptured balloon was unable to properly refold which resulted in the reported difficulty to remove from the introducer sheath. Manipulation and/or inadvertent mishandling of the device during retraction likely resulted in the reported/noted balloon and inner member separation, inner member bunching and balloon wrinkles. There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
 
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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 Key7627634
MDR Text Key111975503
Report Number2024168-2018-04811
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeAS
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 07/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2021
Device Catalogue NumberB1060-080
Device Lot Number80201G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/12/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/24/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2018
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: 06/21/2018 Patient Sequence Number: 1
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