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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 B1140-080
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 04/01/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. (b)(4). The device was received. Investigation is not yet complete. A follow up report will be submitted with all relevant information. The other armada referenced is being filed under a separate medwatch report.
 
Event Description
It was reported that the procedure was to treat the axillary vein. A 14 x 80 mm armada 35 balloon catheter was used; however, the balloon ruptured and the tip separated in an unspecified introducer sheath during removal. A radial tear was noted on the balloon. It was reported that the balloon catheter was hastily removed during deflation. The same issue occurred with a 14 x 40 mm armada 35 balloon catheter. There were no other complications noted and no further treatment was performed. There was no clinically significant delay in the procedure and no adverse patient effects. No additional information was provided.
 
Manufacturer Narrative
(b)(4). A visual inspection was performed and the reported balloon rupture and separation were confirmed. The reported difficulty removing the balloon catheter from the introducer sheath was not tested 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 armada 35 instructions for use (ifu) states: the device is intended for dilatation of lesions in specific arteries. Deflate the balloon by aspirating the inflation syringe or inflation device. Maintaining a vacuum in the balloon, withdraw the catheter. Gentle counterclockwise twisting motion of the balloon may ease withdrawal of the device. The ifu deviations contributed to the reported difficulties as the physician used the device in the wrong anatomy and hastily removed the device during deflation. The investigation determined the reported difficulty to remove through the introducer sheath issue appears to be related to the user error. The reported balloon rupture, balloon/inner member separation and wrinkled materials appears to be related to circumstance of the procedure. There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
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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 Key7487234
MDR Text Key107578168
Report Number2024168-2018-03312
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,Followup
Report Date 05/15/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/04/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2021
Device Catalogue NumberB1140-080
Device Lot Number71117G1
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer04/17/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/11/2018
Was Device Evaluated by Manufacturer? Yes
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

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