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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 B2060-120
Device Problem Torn Material (3024)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/02/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The product was not returned to abbott vascular 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 identified no other similar incidents reported from this lot. The investigation was unable to determine a conclusive cause for the reported shaft tear. 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 an unspecified guide wire was advanced in the patient, and when a 6. 0 x 120 mm armada 35 balloon catheter was placed over the guide wire, the wire came out of the mid shaft of the balloon catheter. Reportedly, a micro hole in the mid shaft was noted, but no leak. The balloon did not enter the patient. Another unspecified balloon catheter was advanced over the guide wire, and the procedure was successfully completed. There was no clinically significant delay in 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 Key7447359
MDR Text Key106160960
Report Number2024168-2018-02933
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 04/20/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2021
Device Catalogue NumberB2060-120
Device Lot Number71118G1
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 Received04/03/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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