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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 B2120-060
Device Problems Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/10/2015
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). The 10x60mm armada 35 referenced is being filed under a separate medwatch mfr number. The device is expected to be returned for investigation. 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 a lesion in the iliac artery with mild tortuosity and mild calcification. After a 14x90 non-abbott stent was implanted, a 12x60mm armada 35 percutaneous transluminal angioplasty (pta) balloon catheter was advanced for post-dilation. The balloon was inflated once and ruptured at 4 atmospheres (atm). The device was removed and replaced with a 10x60mm armada 35 pta balloon catheter that was inflated once and also ruptured at 6 atm. The device was removed and the procedure was ended. There was no adverse patient effect and no clinically significant delay in the procedure. No additional information was provided.

 
Manufacturer Narrative

(b)(4). Evaluation summary: (b)(4). The device was returned for evaluation and the reported balloon rupture was confirmed. Based on visual and scanning electron microscopy imaging analysis of the returned device, there is no indication of a product quality issue with respect to manufacture, design, or labeling. The investigation determined that the reported balloon rupture appears to be due to operational context. A review of the lot history record identified no manufacturing nonconformities. Additionally, a review of the complaint history identified no other incidents from this lot. It should be noted that the armada 35 instruction for use instructs to prepare the device prior to insertion into the patient. Based on the reviewed information, there is no indication the issue was caused by, or related 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 Key5329634
MDR Text Key34998237
Report Number2024168-2015-07999
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeCH
PMA/PMN NumberK111899
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation HEALTH PROFESSIONAL
Remedial Action Other
Type of Report Initial,Followup
Report Date 01/28/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/28/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/30/2018
Device Catalogue NumberB2120-060
Device LOT Number50406G1
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/04/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/19/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/01/2015
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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