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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 10MM4CM 80 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER

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CORDIS CORPORATION POWERFLEXPRO 10MM4CM 80 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER Back to Search Results
Model Number N/A
Device Problems Shaft; Material Puncture / Hole; Catheter
Event Date 09/05/2017
Event Type  Malfunction  
Manufacturer Narrative

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

During a biliary drainage with placement of an endoprosthesis, the doctor had to do a dilatation inside the stent already in place with a 10mm4cm 80 powerflex pro percutaneous transluminal angioplasty (pta) catheter but the balloon used could not inflate. When the balloon has been removed, the radiologist noticed a hole on the device, at its proximal tip. Another similar device from the same lot has been used to complete the procedure. There was no patient injury. The device will be returned for analysis. The inflator displayed a maximal pressure of 6 atm. It was not possible to go above that.

 
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Brand NamePOWERFLEXPRO 10MM4CM 80
Type of DevicePERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER
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
MDR Report Key6913709
Report Number9616099-2017-01484
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 12/27/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/04/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number4401004S
Device LOT Number17687323
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date09/08/2017
Event Location No Information
Date Manufacturer Received12/20/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/23/2017
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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