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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 B1040-040
Device Problems Inflation Problem (1310); Leak/Splash (1354); Torn Material (3024)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/19/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. (b)(6). 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 after preparing 4. 0mm x 40mm x 80cm armada 35 balloon dilatation catheter (bdc) per the instructions for use, the bdc was advanced to the common femoral artery without issue. Two attempts were made to inflate the device, but it was unable to be inflated at all; a small cut on the proximal shaft near the hub was noted to be the origin of the leak and the cause of the inflation failure. The device was withdrawn from the anatomy without issue. A new armada 35 bdc was used successfully to complete the procedure. The patient is doing well. There were no adverse patient effects and no occurrence of a clinically significant delay. No additional information was provided.
 
Manufacturer Narrative
(b)(4). Evaluation summary: visual and functional inspections were performed on the returned device. The reported leak was confirmed to be due to a cracked hub. 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 inflation issue and leak were due to the cracked sidearm; however, a cause for the cracks could not be determined. 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 filed medwatch report, the abbott vascular returned goods lab received the device and noted that the leak originated from a crack in the hub, and not in the proximal shaft itself (as originally reported). Additional information received indicated that while it is believed that the correct device was returned, it is unable to be confirmed by the hospital if the leak and crack had originated from the hub itself, instead of the shaft. 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 Key6327497
MDR Text Key67535520
Report Number2024168-2017-01154
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K111899
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 04/13/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/13/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2020
Device Catalogue NumberB1040-040
Device Lot Number61019G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/31/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/07/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2016
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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