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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 6MM15CM 135 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CORPORATION POWERFLEXPRO 6MM15CM 135 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number 4400615X
Device Problems Partial Blockage; Catheter
Event Date 12/19/2018
Event Type  Malfunction  
Manufacturer Narrative

A review of the manufacturing documentation associated with lot (17719796) presented no issues during the manufacturing process that can be related to the reported event. This is one of two products involved with the reported event and the associated manufacturer report numbers are 9616099-2019-02864. Additional information is pending and will be submitted within 30 days upon receipt.

 
Event Description

During the peripheral angioplasty, the powerflex pro pta (6mm x 15cm 135cm) balloon catheter (bc) did not pass over the guidewire, there was much resistance; therefore, another balloon was used and worked well. There was no reported patient injury. The device was stored and handled per the instructions for use ifu. There was no damage noted to the product packaging upon inspection prior to use. There was no reported difficulty removing the product from the packaging. There were no kinks noted on the device prior to use. The device was prepped according to instructions for use (ifu). The catheter was flushed with heparinized saline. The insertion difficulty was reportedly caused by a blockage of possibly injectable material. There was no excessive force applied on the device while attempting to insert it over the guide wire. Other products were successfully used with the device prior to the encountered resistance. The catheter was not torqued against resistance. There was no unusual force used at any time during the procedure. The difficulty require that only the reported product was removed. The device was removed intact (in one piece) from the patient. The procedure was completed with another balloon. The procedure was completed successfully without patient injury. There are no procedural films available. The device will be returned for analysis. A 6f vista brite tip catheter sheath introducer was used in the procedure. Additional information received indicates that the injection was only a saline solution. There was no thrombus reported.

 
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Brand NamePOWERFLEXPRO 6MM15CM 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 Key8559540
Report Number9616099-2019-02880
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/02/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/27/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number4400615X
Device LOT Number17719796
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/27/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/29/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/22/2017
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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