• 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 5MM15CM 150 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 SABER 5MM15CM 150 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 48005015X
Device Problem Partial Blockage (1065)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/10/2021
Event Type  malfunction  
Event Description
As reported, the scrub nurse tried to flush a saber 5mm15cm 150 but it would not flush. The device was replaced with another saber balloon catheter and it was flushed successfully. There was no reported patient injury. The event did not cause a clinically relevant increase in the duration of the procedure. The event did not cause a condition that requires hospitalization or significant prolongation of existing hospitalization. The device was not used in the patient. The device was opened in the sterile field. The issue occurred during prep for a pta procedure. The device was inspected for damages prior to use and there were no visible damages; only the reported issue. There was no difficulty removing the product from the hoop. The physician also attempted to flush the device but was unable to. It seemed "as if the tip was closed". No solution would the catheter when attempting to flush. The device was later returned for analysis. Addendum: product analysis revealed a piece of an unknown material tucked inside the guide wire lumen could be observed.
 
Manufacturer Narrative
The product history review was completed but has been re evaluated due to need for additional testing. Final updated phr is in process. This device has been analyzed but the final, approved draft of the engineering report and its conclusion is not yet available due to need for additional testing. However, it will be submitted within 30 days upon receipt. Additional information is pending and will be submitted within 30 days upon receipt.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSABER 5MM15CM 150
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 60 avenue
miami lakes, FL 33014
7863138372
MDR Report Key13074925
MDR Text Key290462378
Report Number9616099-2021-05224
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeSF
PMA/PMN Number
K971010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2021
Device Model Number48005015X
Device Catalogue Number48005015X
Device Lot Number82160731
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/27/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/19/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/17/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/23/2021 Patient Sequence Number: 1
Treatment
SABER PTA BALLOON CATHETER (CATALOG #48005010X)
-
-