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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL SLALOM PTA .018 HP 40 6X4 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CASHEL SLALOM PTA .018 HP 40 6X4 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 4396040T
Device Problem Burst Container or Vessel (1074)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/26/2019
Event Type  Malfunction  
Manufacturer Narrative

The device was not returned for analysis. 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

As reported, an attempt was made to deliver the. 018 6 x 4 40 slalom percutaneous transluminal angioplasty (pta) balloon to the stenosis anastomotic part for inflation. However, it was not able to cross. The physician attempted to inflate the front part of a stenosis part only, but it ruptured at six atmospheres (6 atms). The procedure was not completed. The lesion was not inflated. There was no reported patient injury. This was a vascular access intervention therapy (vaivt) case. The lesion was the anatomic part. The device will not be returned for evaluation because it was discarded. The lesion was not calcified. The lesion had acute vessel tortuosity. The percentage of stenosis was 90%. The device was stored and handled per the instructions for use (ifu). 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. The device was prepped per the ifu. There was no kinks or other damages noted prior to inserting the product into the patient. 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. There was no difficulty advancing the balloon catheter through the vessel. The product was removed intact (in one piece) from the patient. Other additional procedural details were requested but were unknown.

 
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Brand NameSLALOM PTA .018 HP 40 6X4
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
CORDIS CASHEL
cahir road
cashel, tipperary 0000
EI 0000
Manufacturer (Section G)
CORDIS CASHEL
cahir road
cashel, tipperary 0000
EI 0000
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
7863138372
MDR Report Key9482065
MDR Text Key199107893
Report Number9616099-2019-03407
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,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/08/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/17/2019
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/30/2020
Device MODEL Number4396040T
Device Catalogue Number4396040T
Device LOT Number17739899
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/20/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured12/08/2017
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: 12/17/2019 Patient Sequence Number: 1
Treatment
MT. FUJI, AAA (B)(4) LLC
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