• 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 SABERX 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 SABERX PTA DILATATION CATHETER; PTA CATHETERS (LIT) Back to Search Results
Catalog Number 51005004L
Device Problem Burst Container or Vessel (1074)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/24/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(6).This device is not available for testing and evaluation.Additional information is pending and will be submitted within 30 days upon receipt.
 
Event Description
During an unspecified interventional procedure, a saber x ruptured at 6 atmospheres (atm) during its second dilatation.It was changed to another balloon to complete the procedure.The procedure was finished successfully.There was no reported patient injury.The product will not be returned for analysis.The target lesion was the external iliac artery.The rate of stenosis was unknown.A contralateral approach was made for heavily calcified.A saber balloon was delivered to the lesion.However, it ruptured at 6atm during its second-dilation and the leakage of media was observed.There was 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 the product into the patient.The device prepped normally.The brand of contrast and the contrast to saline ratio are unknown.The brand of inflation device was used is also unknown.It is unknown if the same indeflator was used successfully with other devices.It is unknown if there was any resistance/friction while inserting the balloon through the rotating hemostatic valve or while inserting the balloon through the guide catheter.It is unknown if there was any difficulty advancing the balloon catheter through the vessel and if there was any difficulty crossing the lesion.It is also unknown if the catheter was ever in an acute bend.It is unknown if the balloon inflated normally or if leakage was noted from the balloon, shaft, hub, or from an unknown segment.It is also unknown if the balloon catheter kinked while being used.It is unknown if the balloon catheter removed easily from the vessel and from the other devices.
 
Manufacturer Narrative
During an unspecified interventional procedure, a saber x ruptured at 6 atm (six atmospheres) during its second dilatation.It was changed to another balloon to complete the procedure.The procedure was finished successfully.There was no reported patient injury.The target lesion was the external iliac artery.The rate of stenosis was unknown.A contralateral approach was made for the vessel was heavily calcified.A saber balloon was delivered to the lesion.However it ruptured at 6 atm during its second-dilation and the leakage of media was observed.There was 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 the product into the patient.The device prepped normally.The brand of contrast and the contrast to saline ratio are unknown.The brand of inflation device was used is also unknown.It is unknown if the same indeflator was used successfully with other devices.It is unknown if there was any resistance/friction while inserting the balloon through the rotating hemostatic valve or while inserting the balloon through the guide catheter.It is unknown if there was any difficulty advancing the balloon catheter through the vessel and if there was any difficulty crossing the lesion.It is also unknown if the catheter was ever in an acute bend.It is unknown if the balloon inflated normally or if leakage was noted from the balloon, shaft, hub, or from an unknown segment.It is also unknown if the balloon catheter kinked while being used.It is unknown if the balloon catheter removed easily from the vessel and from the other devices.The product will not be returned for analysis.A device history record (dhr) review of lot 17279964 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst-at/below rbp (peripheral)¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Vessel characteristics of heavy calcification may have contributed to the reported event.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 Name
SABERX PTA DILATATION CATHETER
Type of Device
PTA 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
MX   32580
7863133880
MDR Report Key5311906
MDR Text Key33935105
Report Number9616099-2015-00666
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 11/25/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/31/2018
Device Catalogue Number51005004L
Device Lot Number17279964
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/25/2015
Initial Date FDA Received12/18/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received01/15/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/09/2015
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
-
-