• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CORDIS CORPORATION POWERFLEXPRO 6MM15CM 135 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number 4400615X
Device Problems Balloon; Partial Blockage; Catheter
Event Date 10/08/2018
Event Type  Malfunction  
Manufacturer Narrative

As reported, a 0. 035 non-cordis guidewire failed to pass through the balloon shaft of the 6x150mm 135 cm powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter (bc). The insertion difficulty of the wire could have potentially been caused by a blockage of material that could be inserted into the patient and cause harm. The device was replaced with a non-cordis balloon to complete the operation, and the procedure was completed successfully. No patient injury was reported. The target lesion vessel diameter was 6mm. The lesion was seventy percent calcified and there was no vessel tortuosity. The vessel had seventy percent stenosis and the device was used for a chronic total occlusion (cto). The malfunction occurred during use. The intended procedure was a balloon post-dilated stent implantation. The product was stored, handled, inspected and prepped according to the instructions for use (ifu). The product prepped normally. There was no difficulty removing the product from the hoop, no difficulty removing the protective balloon cover, and no difficulty removing the stylet or any of the sterile packaging components. There were no kinks or other damages noted prior to inserting the product into the patient. There were no anomalies noted to the guidewire and no kinks or bends. The same guidewire was used successfully with other devices. There was difficulty experienced when advancing the balloon catheter and it failed to pass through the vessel. The catheter was never in an acute bend. There were no anomalies noted to the balloon after it was removed from the patient and it was removed intact (in one piece). There was no unusual force used at any time during the procedure. The device was not returned for analysis. A device history record (dhr) review of lot 17736306 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event. The reported ¿guidewire lumen obstructed during use¿ could not be confirmed as the device was not returned for analysis. The exact cause of the obstruction reported could not be determined. Based on the information available for review, it is not possible to determine what factors may have contributed to the issue reported since the customer stated there were no damages noted to the device or wire, and it was prepped accordingly. If an injectable obstruction was possible, it could have been detected during flushing of the guidewire lumen. Therefore, handling factors are possible. As warned in the instructions for use (ifu), which is not intended as a mitigation, ¿if resistance is met during manipulation, determine the cause of the resistance before proceeding. Proper functioning of the catheter depends on its integrity. Care should be used when handling the catheter. Damage may result from kinking, stretching, or forceful wiping of the catheter. Forceful handling can result in catheter separation and the subsequent need to use a snare or other medical interventional techniques to retrieve the pieces. Prior to angioplasty, the catheter should be examined to verify functionality and integrity, and ensure that its size and shape are suitable for the specific procedure for which it is to be used. Do not use if product damage is evident. ¿ the ifu also states, ¿flush the ¿thru¿ lumen with sterile heparinized saline or a similar isotonic solution. Place the prepared catheter over a prepositioned guidewire and advance the tip to the introduction site. ¿ based on the device history record (dhr) review and the information available for review, there is no indication that the event is related to the device manufacturing process. Therefore, no corrective actions will be taken at this time.

 
Event Description

As reported, a 0. 35 non-cordis guidewire failed to pass through the balloon shaft of the 6mmx15cm powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter (bc). No patient injury was reported. The target lesion vessel diameter was 6mm. The lesion was seventy percent calcified and there was no vessel tortuosity. The vessel had seventy percent stenosis and the device was used for a chronic total occlusion (cto). The malfunction occurred during use. The intended procedure was a balloon post-dilated stent implantation. The product was stored, handled, inspected and prepped according to the instructions for use (ifu). The product prepped normally. There was no difficulty removing the product from the hoop, no difficulty removing the protective balloon cover, and no difficulty removing the stylet or any of the sterile packaging components. There were no kinks or other damages noted prior to inserting the product into the patient. There were no anomalies noted to the guidewire and no kinks or bends. The same guidewire was used successfully with other devices. The insertion difficulty of the wire could have potentially been caused by a blockage of material that could be inserted into the patient and cause harm. There was difficulty experienced when advancing the balloon catheter and it failed to pass through the vessel. The catheter was never in an acute bend. There were no anomalies noted to the balloon after it was removed from the patient and it was removed intact (in one piece). There was no unusual force used at any time during the procedure. The device was replaced with a non-cordis balloon to complete the operation, and the procedure was completed successfully.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePOWERFLEXPRO 6MM15CM 135
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60 avenue
miami lakes FL 33014
Manufacturer (Section G)
CORDIS CORPORATION
14201 nw 60 avenue
miami lakes FL 33014
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes , FL 33014
7863138372
MDR Report Key8023794
Report Number9616099-2018-02481
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 12/06/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/31/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number4400615X
Device LOT Number17736306
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/14/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/14/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/17/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-