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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORRATION POWERFLEXPRO 7MM4CM 80 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CORPORRATION POWERFLEXPRO 7MM4CM 80 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number N/A
Device Problems Decrease in Pressure (1490); Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/17/2019
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: balloon catheter (7*40 ultraverse, c. R. Bard), brite tip sheath 6fr-11cm, guidewire- vassallo floppy 300 (filmec). Telephone number is : (b)(6). The device was not returned for analysis. A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan. Additional information is pending and will be submitted within 30 days upon receipt.
 
Event Description
During post-dilatation of an 8x40 smart stent that was deployed in the left external iliac artery with a 7mm4cm 80 powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter, the balloon ruptured within nominal pressure. It was replaced with a non cordis pta catheter and the procedure was completed. There was no patient injury and the device was discarded by mistake. Initial approach to the lesion was made from the left femoral artery. The powerflex pro was used for pre-dilation and the smart stent was implanted. The lesion was a 100% occluded chronic total occlusion with severe calcification (70%) and mild vessel tortuosity. There was no difficulty removing the product from the hoop, no difficulty removing the protective balloon cover and no difficulty removing the stylet or any of the sterile packaging components. There were no kinks or other damages noted prior to inserting the product the product into the patient. The device prepped normally. The same indeflator was used successfully with other devices. There was no resistance/friction while inserting the balloon through the rotating hemostatic valve. There was no difficulty crossing the lesion and the catheter was never in an acute bend. Additional procedural details were requested but were not available.
 
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Brand NamePOWERFLEXPRO 7MM4CM 80
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
CORDIS CORPORRATION
14201 nw 60th ave
miami lakes FL 33014
Manufacturer (Section G)
CORDIS CORPORATION
14201 nw 60th ave
miami lakes FL 33014
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
7863138372
MDR Report Key9180403
MDR Text Key195586017
Report Number9616099-2019-03269
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K112797
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/16/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2021
Device Model NumberN/A
Device Catalogue Number4400704S
Device Lot Number82157745
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 Received10/14/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/02/2018
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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