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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 B2060-060
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 04/05/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The incident information was reviewed; however, the product was not returned to abbott vascular for analysis. 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 was unable to determine a conclusive cause for the reported balloon rupture. The reported difficulty removing the device causing the balloon separation appears to be related to circumstances of the procedure. There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.
 
Event Description
It was reported that procedure was to treat a lesion in a heavily calcified, 80% stenosed, right superficial femoral artery. A 6 x 60 mm armada 35 percutaneous transluminal angioplasty (pta) catheter was advanced to the lesion without resistance. The balloon was inflated to 10 atmospheres, but on the second inflation the balloon ruptured before reaching nominal pressure. During removal of the pta catheter from the anatomy, the balloon caught on the edge of the unspecified 6f short introducer sheath and a portion of the balloon separated from the shaft. The pta catheter was removed from the anatomy. The 6f short introducer sheath was removed from the anatomy and replaced with a longer introducer sheath in an unsuccessful attempt to capture the balloon fragment. A cut down procedure was performed to remove the balloon fragment from the anatomy. The procedure was completed with the successful deployment of an unspecified stent implant. No additional information 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 Key7459268
MDR Text Key106464855
Report Number2024168-2018-03049
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K111899
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 04/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/25/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2021
Device Catalogue NumberB2060-060
Device Lot Number71110G1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/05/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2017
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: 04/25/2018 Patient Sequence Number: 1
Treatment
INTRODUCER SHEATH: 6F SHORT SHEATH
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