• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDINAL HEALTH MEXICO 244 S DE RL DE CV SABER RX8MM4CM155 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
 

CARDINAL HEALTH MEXICO 244 S DE RL DE CV SABER RX8MM4CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number N/A
Device Problems Burst Container or Vessel (1074); Separation Failure (2547)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/05/2021
Event Type  malfunction  
Manufacturer Narrative
Telephone number is : (b)(6). Please note that the saber balloon in this report is not sold in the u. S. However, it is similar to other saber/cordis pta balloon catheters that are sold in the u. S. The device was returned but the engineering report is pending. A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan. Additional information is pending and will be submitted within 30 days upon receipt.
 
Event Description
While slowly inflating an 8mm x 4cm saber rx percutaneous transluminal angioplasty (pta) balloon catheter in the left iliac artery, the pressure was between 10 and 12 atmospheres (atm) when it ruptured. The physician attempted to re-sheath, but the saber pta catheter separated at approximate 5 cm from the distal end. Therefore, the complaint device and the guidewire were removed by incision and the procedure completed. 4 photographs were provided. The 95% occluded lesion had almost no calcification and no vessel tortuosity. An ipsilateral retrograde approach was (initially) made. A 6f non-cordis sheath was inserted, and a guidewire was inserted and advanced. The saber pta balloon catheter was used after ivus was checked. The access site was the left femoral artery. There was no difficulty removing the complaint balloon from the forming tube. There were no kinks or other damages noted prior to inserting the product the product into the patient. The device prepped normally. The saline to contrast ratio was 2:1. There was no resistance/friction while inserting the balloon through the rotating hemostatic valve and no resistance/friction while inserting the balloon through the guide catheter. There was no difficulty advancing the balloon catheter through the vessel and no difficulty crossing the lesion. The catheter was in an acute bend. It did not kink while being used or kink in the area of separation. There was no resistance met while withdrawing the device. Patient information was requested but was not available. The device will be returned for analysis.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSABER RX8MM4CM155
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
CARDINAL HEALTH MEXICO 244 S DE RL DE CV
santiago troncoso 808
juarez 32574
MX 32574
Manufacturer (Section G)
CARDINAL HEALTH MEXICO 244 S DE RL DE CV
santiago troncoso 808
juarez 32574
MX 32574
Manufacturer Contact
karla castro
14201 nw 60th ave,
miami lakes, FL 33014
7863138372
MDR Report Key12703587
MDR Text Key278535546
Report Number9616099-2021-05010
Device Sequence Number1
Product Code LIT
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,Followup
Report Date 12/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number51008004L
Device Lot Number82189821
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/26/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/30/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/26/2020
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: 10/27/2021 Patient Sequence Number: 1
Treatment
6F TERUMO SHEATH AND VASSALLO FLOPPY GUIDEWIRE (FI
-
-