• 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 RX6MM4CM155 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 RX6MM4CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 51006004L
Device Problem Burst Container or Vessel (1074)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/10/2022
Event Type  malfunction  
Manufacturer Narrative
A review of the manufacturing documentation associated with lot 82222005 presented no issues during the manufacturing process that can be related to the reported event. Additional information is pending and will be submitted within 30 days upon receipt.
 
Event Description
As reported, the balloon of a saber rx 6mm 4cm 155 ruptured at 8atm. The device was delivered and inflated at the lesion in the superficial femoral artery (sfa). There was no reported injury to the patient. The product was stored properly according to the instructions for use (ifu). There was no difficulty removing the product from the hoop. There was no difficulty removing the protective balloon cover, stylet, or any of the sterile packaging components. The device was prepped per the ifu. The device was prepped normally and was sable to maintain negative pressure. The procedure being performed was an evt in the superficial femoral artery (sfa). The vessel was noted to have mild tortuosity and the lesion to have mild calcification. The lesion had a 90% stenosis. The device was not being used to treat a chronic total occlusion. There was no resistance/friction while inserting the balloon through the rotating hemostatic valve. There was no resistance/friction while inserting the balloon through the guide catheter. The device did not have any difficulty while advancing through the vessel or while crossing the lesion. It was noted that the device was at some point in an acute bend; however, it was never kinked while being used. The device was removed intact (in one piece) from the patient). The case was completed after the use of an unknown device. The device will not be returned as it was discarded.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSABER RX6MM4CM155
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
miamilakes FL 33014
Manufacturer Contact
karla castro
14201 nw 60 avenue
miami lakes, FL 33014
7863138372
MDR Report Key14000031
MDR Text Key290097252
Report Number9616099-2022-05506
Device Sequence Number1
Product Code LIT
UDI-Device Identifier20705032076101
UDI-Public(01)20705032076101(17)240531(10)82222005
Combination Product (y/n)N
Reporter Country CodeJA
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 04/17/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/04/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number51006004L
Device Catalogue Number51006004L
Device Lot Number82222005
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/05/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/15/2021
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: 04/04/2022 Patient Sequence Number: 1
Treatment
UNK BALLOON CATHETER
-
-