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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 B1060-040
Device Problem Torn Material (3024)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/12/2018
Event Type  malfunction  
Manufacturer Narrative
Internal file number - (b)(4). Evaluation summary: visual inspection was performed on the returned device. The reported torn/ruptured balloon was confirmed. It was reported that the balloon was not prepped outside of the anatomy. It should be noted that the armada 35 instruction for use (ifu) instructs to prepare the balloon prior to introduction of the system into the anatomy. 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 similar incidents. 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.
 
Event Description
Subsequent to the initial report, additional information was provided. Returned device analysis revealed that the balloon was inflated and there was a rupture observed. The device was inflated once at 20 atmospheres when it ruptured. No additional information was provided.
 
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 eccentric de novo distal superficial femoral artery. A 6. 0 x 40 mm armada 35 balloon catheter was used; however, the balloon could not be inflated because it was noted to be torn. Therefore, the device was replaced with another unspecified armada balloon catheter to successfully complete the procedure. 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
MDR Report Key7238025
MDR Text Key285549039
Report Number2024168-2018-00786
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
PMA/PMN Number
K111899
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Remedial Action Other
Type of Report Initial,Followup
Report Date 03/19/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2021
Device Catalogue NumberB1060-040
Device Lot Number41027G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/05/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/19/2018
Is This a Reprocessed and Reused Single-Use Device? No

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