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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 B1120-080
Device Problems Detachment Of Device Component (1104); Difficult to Remove (1528); Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/02/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Internal file number - (b)(4) : during processing of this complaint, attempts were made to obtain complete event, patient and device information. Above rated burst pressure. The incident information was reviewed; however, the product was not returned to abbott vascular for analysis. It should be noted that armada 35 instructions for use states: inflation in excess of the rated burst pressure may cause the balloon to rupture. Use of a pressure monitoring device is recommended. When post-dilating stents, use a balloon length that is appropriate for the deployed stent length. In this case, the physician did not follow the recommended instructions for use and pressurized the balloon above rated burst pressure which resulted in the reported balloon rupture. 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 balloon rupture appears to be related to the user error and the balloon was inflated above rated burst pressure. The reported balloon detachment and difficult to remove appear to be related to circumstances of the procedure. There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Event Description
It was reported that the procedure was to treat a lesion in the brachial artery. A 12x80mm armada 35 balloon ruptured during the first inflation at 12 atmospheres. Resistance was felt removing the balloon catheter and was thought to be with the struts of a previously implanted stent. The balloon catheter was removed; however, after removal it was noticed that the distal shaft, where the balloon is located, had separated. The procedure was successfully completed after removal of the balloon catheter. There was no clinically significant delay in the procedure and no adverse patient effects. No additional information was 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 Key7434624
MDR Text Key105771045
Report Number2024168-2018-02821
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 04/16/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/16/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2021
Device Catalogue NumberB1120-080
Device Lot Number80102G1
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 Received04/02/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/01/2018
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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