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

MAUDE Adverse Event Report: CORDIS CASHEL SABER RX5MM15CM155 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 CASHEL SABER RX5MM15CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 51005015L
Device Problem Defective Component (2292)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/10/2019
Event Type  malfunction  
Manufacturer Narrative
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. This device is available for analysis, but the engineering report is not yet available. However, it will be submitted within 30 days upon receipt.
 
Event Description
As reported, a saber balloon catheter (rx5mm15cm155) was delivered to the lesion in the superficial femoral artery for pre-dilation prior to implantation of a non-cordis stent. The device was initially inflated to 8 atmospheres (atms), however, during a second inflation, the balloon ruptured at 10 atms. The lesion was described as a chronic total occlusion. Initially, a contralateral approach was made to the lesion using an unknown guidewire. It was reported that the balloon catheter did not catch on anything during delivery to the lesion. The vessel and lesion were not calcified. The device was replaced with another saber balloon catheter and the procedure was completed. There was no patient injury reported. The device was clinically used and will be returned for analysis. There was no difficulty removing the product from the hoop. There was no difficulty removing the protective balloon cover. 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 into the patient. The device prepped normally. The inflation device used was a non-cordis device. The same indeflator was used successfully with other devices. There was no resistance/friction encountered while inserting the balloon through the rotating hemostatic valve. There was no resistance/friction encountered while inserting the balloon through the 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 balloon catheter did not kink while being used. The product was removed intact (in one piece) from the patient.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSABER RX5MM15CM155
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
CORDIS CASHEL
cahir road
cashel, co. tipperary
EI
Manufacturer (Section G)
CORDIS CASHEL
cahir road
cashel, co. tipperary
EI
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
7863138372
MDR Report Key8682392
MDR Text Key147462216
Report Number9616099-2019-03004
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/10/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2019
Device Model Number51005015L
Device Catalogue Number51005015L
Device Lot Number17562056
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/30/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/13/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/16/2016
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: 06/10/2019 Patient Sequence Number: 1
Treatment
VIABAHN STENT, UNK GW, ATM2-30 LIFELINE INDEFLATOR
-
-