• 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 SLALOM PTA .018 HP 40 5X4 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 SLALOM PTA .018 HP 40 5X4 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 4395040T
Device Problem Burst Container or Vessel (1074)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/24/2019
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical product: boston scientific symmetry balloon catheter. Complaint conclusion: a slalom. 018 hp 40 5 x 4 percutaneous transluminal angioplasty (pta) balloon catheter (bc) was inserted and inflated the lesion; however, it ruptured at around eight atmospheres (8atm). There was no reported patient injury. It was replaced with a non-cordis bc and the procedure was completed. The product was not returned for analysis. A product history record (phr) review of lot 17726074 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event. The reported ¿balloon burst-at/below rbp¿ could not be confirmed as the device was not returned for analysis. The exact cause could not be determined. There is no additional information regarding patient, lesion or procedural characteristics regarding this event. With the paucity of information available and without the return of the product or films of the procedure it is difficult to draw a clinical conclusion between the device and the event reported. However, vessel characteristics and procedural factors may have contributed to the reported event. According to the instructions for use, which are not intended to mitigate risk, ¿balloon pressure should not exceed the rated burst pressure. The rated burst pressure is based on the results of in vitro testing. At least 99. 9% of the balloons (with a 95% confidence), will not burst at or below their rated burst pressure. Use of a pressure monitoring device is recommended to prevent over pressurization. Caution: fully deflate the balloon by inducing negative pressure with the inflation system whenever the pta catheter is advanced or withdrawn. Do not advance or withdraw the pta catheter within the vasculature unless the catheter is preceded by a guidewire. Caution: if strong resistance is met during advancement or withdrawal of the catheter, discontinue movement and determine the cause of resistance before proceeding. If the cause of resistance cannot be determined, withdraw the entire system. Remove the vacuum (do not apply pressure) and withdraw the catheter. Note: gentle counterclockwise rotation of the balloon may ease withdrawal from the sheath or from the percutaneous entry site. If the balloon cannot be withdrawn through the sheath or guiding catheter, check if the balloon is fully deflated. If not, withdraw the catheter and sheath as one unit. ¿ neither the phr nor the information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.
 
Event Description
As reported, a slalom. 018 hp 40 5x4 percutaneous transluminal angioplasty (pta) balloon catheter (bc) was inserted and inflated the lesion, however, it ruptured at around 8 atmospheres (atm). There was no reported patient injury. It was replaced with a non-cordis bc and the procedure was completed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSLALOM PTA .018 HP 40 5X4
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 Key8727964
MDR Text Key148983165
Report Number9616099-2019-03036
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K003159
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
Report Date 06/24/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/24/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2020
Device Model Number4395040T
Device Catalogue Number4395040T
Device Lot Number17726074
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/25/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/12/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-