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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 B1080-080
Device Problems Inflation Problem (1310); Loose or Intermittent Connection (1371)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/25/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. 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 that the procedure was to treat a mildly tortuous and mildly calcified de novo lesion in the mid iliac artery. An 8x80mm armada 35 balloon catheter failed to inflate. It was noticed that the balloon port on the device would not lock properly onto the indeflator, contrast was leaking everywhere out of the port. The procedure was successfully completed with a drug coated balloon. There was no clinically significant delay in the procedure and no adverse patient effects. No additional information was provided.
 
Manufacturer Narrative
(b)(4). Evaluation summary: visual and functional inspection was performed on the returned device. The reported inflation issue was confirmed to be due to a cracked hub. It is likely that rotator on the syringe or flushing device was over-tightened causing the sidearm to crack at the threads. 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 from this lot. The investigation determined the reported difficulties appear to be related to circumstances of the procedure. 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 Key6567423
MDR Text Key75319373
Report Number2024168-2017-04155
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 06/07/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/15/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2020
Device Catalogue NumberB1080-080
Device Lot Number61219G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/22/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/02/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2016
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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