• 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 SABER PTA DILATATION CATHETER PTA CATHETERS (LIT)

  • 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 SABER PTA DILATATION CATHETER PTA CATHETERS (LIT) Back to Search Results
Catalog Number 48003015S
Device Problems Shaft; Material Puncture / Hole; Catheter
Event Date 02/26/2016
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

As reported, during use it was noticed the shaft was pierced at the base of the balloon of a saber 3mm 15cm 90 percutaneous transluminal angioplasty (pta) balloon catheter. They changed out the device and used another device (saber 3 mm) to complete the procedure successfully. There was no report of patient injury. The device will be returned for analysis. Details regarding patient anatomy include no tortuosity, severe calcification and 95% stenosis. There were no damages or anomalies noted to the device or packaging prior to use. There was no reported difficulty removing the product from the packaging. The product was stored, handled and prepped properly according to the instructions for use (ifu). There were no difficulties advancing the catheter through the sheath introducer. There were no difficulties advancing the catheter to the target lesion. The intended procedure was treatment of pre-occlusive popliteal stenosis, ischemia of level iv, right inferior member and leg arthritis.

 
Manufacturer Narrative

A review of the device history record revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint. Additional information is pending and will be submitted in 30 days upon receipt.

 
Manufacturer Narrative

During use it was noticed that the shaft was pierced at the base of the balloon of a saber 3mm x 15cm 90cm percutaneous transluminal angioplasty (pta) balloon catheter. They changed out the device and used another device (saber 3 mm) to complete the procedure successfully. There was no report of patient injury. Details regarding patient anatomy include no tortuosity, severe calcification and 95% stenosis. There were no damages or anomalies noted to the device or packaging prior to use. There was no reported difficulty removing the product from the packaging. The product was stored, handled and prepped properly according to the instructions for use (ifu). There were no difficulties advancing the catheter through the sheath introducer. There were no difficulties advancing the catheter to the target lesion. The intended procedure was treatment of pre-occlusive popliteal stenosis, ischemia of level iv, right inferior member and leg arthritis. The device was not returned for analysis. A device history record (dhr) review of lot 17301817 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event. The reported ¿body/shaft puncture/cut (peripheral)¿ could not be confirmed as the device was not returned for analysis. The exact cause could not be determined. Vessel characteristics of severe calcification and a rate of stenosis of 95% may have contributed to the reported event. According to the ifu ¿open the pouch, grasp the hub and gently take the catheter out. Do not use if inner package is opened or damaged. 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 suspected or evident. ¿ neither the dhr nor the information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSABER PTA DILATATION CATHETER
Type of DevicePTA CATHETERS (LIT)
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60th avenue
miami lakes FL
Manufacturer Contact
cecil navajas
circuito interior norte #1820
juarez chihuahua  32580
  32580
7863133880
MDR Report Key5507802
Report Number9616099-2016-00143
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 02/26/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/17/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/30/2018
Device Catalogue Number48003015S
Device LOT Number17301817
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/11/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/20/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

-
-