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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 B2070-040
Device Problems Material Rupture (1546); Material Separation (1562)
Patient Problem Vessel Or Plaque, Device Embedded In (1204)
Event Date 06/21/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The device was not returned 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 revealed no other incidents. The investigation determined that the reported difficulties appear to be due to case circumstances. It is likely that the rupture occurred due to interaction with the lesion site. The separation during removal likely occurred when removing the catheter and the ruptured balloon material caught on the introducer sheath. There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
 
Event Description
It was reported that the procedure was to treat an 80% stenosed lesion located in the tibial artery. The 7 x 40 mm armada 35 balloon catheter ruptured transversely upon inflation. After removal of the balloon catheter from the anatomy it was observed that the tip of the catheter had separated from the catheter and remained in the patient. A stent was used to crush the separated tip against the vessel wall. As this was the end of the procedure no further treatment was performed. No additional information was provided.
 
Manufacturer Narrative
Internal file number - (b)(4). Correction: the "date received by manufacturer" was filed incorrectly on the initial medwatch report as 06/28/2018, but should have been 06/26/2018.
 
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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 Key7675235
MDR Text Key113587155
Report Number2024168-2018-05211
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 Risk Manager
Remedial Action Other
Type of Report Initial,Followup
Report Date 07/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/10/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2021
Device Catalogue NumberB2070-040
Device Lot Number80105G1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/16/2018
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

Patient Treatment Data
Date Received: 07/10/2018 Patient Sequence Number: 1
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