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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 Detachment Of Device Component (1104); Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/04/2018
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 is expected to be returned for evaluation. It has not yet been received. A follow up report will be submitted with all additional relevant information.
 
Event Description
It was reported that the procedure was to treat an 80% stenosed dialysis shunt. An armada 35 balloon dilatation catheter (bdc) was used at a high pressure for dilatation; however, the balloon ruptured during the first inflation. Part of the balloon and the tip of the catheter separated and were lost in the patient. Surgery was performed to remove the separated portions. No additional information was provided.
 
Manufacturer Narrative
(b)(4). Correction: manufacturing site. Evaluation summary: visual analysis was performed on the returned device. The reported balloon rupture and separation was confirmed. 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 incidents from this lot. The investigation determined that the reported difficulties were due to case circumstances. It is likely that the balloon rupture was the result of interaction with the lesion site which was described as concentric with 80% restenosis. The separation likely occurred due to the ruptured balloon material catching on the introducer sheath during removal. 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 Key7627922
MDR Text Key111976486
Report Number2024168-2018-04815
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K111899
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 07/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2020
Device Catalogue NumberB1080-080
Device Lot Number70717G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/03/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/12/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2017
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: 06/21/2018 Patient Sequence Number: 1
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