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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 6MM2CM 80 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CORPORATION POWERFLEXPRO 6MM2CM 80 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number 4400602S
Device Problem Burst Container or Vessel (1074)
Patient Problem Not Applicable (3189)
Event Date 07/13/2018
Event Type  malfunction  
Manufacturer Narrative
A review of the manufacturing documentation associated with lot 17633516 presented no issues during the manufacturing process that can be related to the reported event. Additional information is pending and will be submitted within 30 days upon receipt.
 
Event Description
As reported, a 80 6 mm x 2 cm powerflex pro was inflated and ruptured at ten atmospheres (10 atm). No patient injury was reported. The lesion was the superficial femoral artery (sfa) with calcification. After the balloon ruptured it was replaced with a same size non-cordis balloon catheter (bc) and inflated at fifteen atmospheres (15 atm) to complete the procedure. The product has been discarded in the hospital and will not be returned for analysis due to the patient having a suspicious infectious disease.
 
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Brand NamePOWERFLEXPRO 6MM2CM 80
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
CORDIS CORPORATION
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 Key7769837
MDR Text Key117158969
Report Number9616099-2018-02303
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,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/22/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/09/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2019
Device Catalogue Number4400602S
Device Lot Number17633516
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 Received08/15/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/14/2017
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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