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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 8MM4CM 80 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CORPORATION POWERFLEXPRO 8MM4CM 80 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 4400804S
Device Problem Burst Container or Vessel (1074)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/12/2019
Event Type  Malfunction  
Manufacturer Narrative

Additional information to include from facility name: social welfare corporation (b)(6) general hospital. Phone number: (b)(6).

 
Event Description

As reported, the 6mm x 10cm x 80 powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter (bc) ruptured at its approximate rated balloon pressure during its second inflation. There was no reported patient injury. The device was used as a post dilation after a smart stent was implanted. The lesion was the iliac artery. The device was replaced with another balloon catheter. The device will not be returned for evaluation because it was discarded.

 
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Brand NamePOWERFLEXPRO 8MM4CM 80
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60th avenue
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 Key9440441
MDR Text Key199106482
Report Number9616099-2019-03392
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK112797
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/06/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/09/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number4400804S
Device Catalogue Number4400804S
Device LOT Number82160009
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/11/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured09/12/2018
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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