• 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 3.5MM20CM 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 3.5MM20CM 150 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 48003520X
Device Problems Leak/Splash (1354); Device Markings/Labelling Problem (2911); Appropriate Term/Code Not Available (3191)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/10/2021
Event Type  malfunction  
Manufacturer Narrative
Suspect tampering. A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint. It is unknown if the device will be returned for testing and evaluation.    additional information is pending and will be submitted within 30 days upon receipt.
 
Event Description
As reported, the body of a 3. 5mm x 20cm x 150cm saber percutaneous transluminal angioplasty (pta) balloon catheter was leaked. It was also noted that the device was used beyond expiration date. There is an over-label process in (b)(6). Only 1 product/unit were received in this condition. The affected lot was sold to the account prior to the expiration date. Per affiliate, preliminary judgment is that the previous dealer who bought this product had fabricated the english and (b)(6) labeling. Business with this previous dealer has been terminated. This product was handed over to the new dealer from the old dealer. The new dealer could not identify the fake labeling. There was no reported patient injury. The intended procedure was a superficial femoral occlusion. The leakage was noted during use. The lesion was not calcified. There was no vessel tortuosity. The percentage of stenosis was 80%. The device was not used for a chronic total occlusion (total occlusion >3 months). There was no difficulty removing the product from the hoop, the protective balloon cover, or the stylet or any of the sterile packaging components. There were no kinks nor other damages noted prior to inserting the product into the patient. The device was prepped normally (i. E. , maintain negative pressure). Ge contrast media was used. The contrast to saline ratio was 1:1. A non-cordis inflation device was used. The same indeflator was not used successfully with other devices. There was no resistance/friction while inserting the balloon through the rotating hemostatic valve or guide catheter. There was no difficulty advancing the balloon catheter through the vessel. There was no difficulty crossing the lesion. The catheter was never in an acute bend. The plunger did not depress into the syringe/indeflator when trying to inflate. The balloon catheter did not kink while being used. The balloon catheter was removed easily. The product was removed intact (in one piece) from the patient. The procedure was completed by changing the device with another balloon. The device will be returned for evaluation.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSABER 3.5MM20CM 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 11000
Manufacturer Contact
karla castro
14201 nw 60 avenue
miami lakes, FL 33014
7863138372
MDR Report Key11954833
MDR Text Key258294867
Report Number9616099-2021-04614
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K971010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 08/04/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2020
Device Model Number48003520X
Device Catalogue Number48003520X
Device Lot Number17647576
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/03/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/24/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-