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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEX EXTREME 8X4 80CM CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CORPORATION POWERFLEX EXTREME 8X4 80CM CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 4158040S
Device Problem Difficult to Open or Remove Packaging Material (2922)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/20/2020
Event Type  malfunction  
Manufacturer Narrative
A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint. This device is available for analysis but has not yet been received. Additional information is pending and will be submitted within 30 days upon receipt.
 
Event Description
As reported, the sterile pouch of an 8mm x 4mm 80cm powerflex extreme percutaneous transluminal angioplasty (pta) balloon catheter was never sealed at the bottom. There was no reported patient injury. The pouch was not previously opened. The packaging had not been damaged. The package was not opened for a patient and it was noticed before ever needing to be used. The device is expected to be returned for evaluation. Images were available for review. Image 1 was reviewed. Upon review, it appears the seal is missing from an unknown inner package. Image 2 was reviewed. Upon review, this appears to be an image of what the seal is supposed to look like, or possibly showing the other end of the packaging is as it should be. Image 3 was reviewed. Upon review, this is a photo of a powerflex extreme label with the device in its original packaging.
 
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Brand NamePOWERFLEX EXTREME 8X4 80CM
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60 avenue
miami 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 Key9972587
MDR Text Key200516892
Report Number9616099-2020-03652
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K032737
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 06/09/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number4158040S
Device Catalogue Number4158040S
Device Lot Number82180077
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/29/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/29/2019
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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