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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 10MM4CM 135 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CORPORATION POWERFLEXPRO 10MM4CM 135 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number N/A
Device Problems Crack (1135); Catheter (3038); Tip (3123)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/27/2019
Event Type  Malfunction  
Manufacturer Narrative

This device is available for analysis but the engineering report is not yet available. However, it will be submitted within 30 days upon receipt.

 
Event Description

During a stenting procedure and inflation of a 10 mm 4 cm 135 powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter for balloon angioplasty, the balloon was unable to be inflated and when it was removed, the head tip of the balloon was broken with the contrast agent ejecting from the break. It was replaced with the same model balloon and the procedure was successfully completed. There was no patient injury and the device will be returned for analysis. Before opening the product, the package was not damaged. The package was opened, the balloon catheter was removed and the preparation steps for flushing. After the balloon was delivered to the expanded target position along the guide wire, the balloon was filled with the pressure pump, and the balloon was unable to be inflated to the standard form at all times with the pressure pump.

 
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Brand NamePOWERFLEXPRO 10MM4CM 135
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 Key9099969
MDR Text Key159632641
Report Number9616099-2019-03215
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeCH
PMA/PMN NumberK112797
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 10/17/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/20/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number4401004X
Device LOT Number17737311
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/16/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/01/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/28/2017
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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