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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL SABER 4MM30CM 150 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CASHEL SABER 4MM30CM 150 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number 48004030X
Device Problem Burst Container or Vessel (1074)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/14/2019
Event Type  Malfunction  
Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.

 
Event Description

As reported, a 4 x 300mm saber percutaneous transluminal angioplasty (pta) balloon catheter ruptured at 13 atm (atmospheres) while treating a lesion in the popliteal and distal superficial artery (sfa). There was no patient injury reported. The device will not be returned for evaluation. The device was stored in the cath lab for approximately 12 months as per instructions for use (ifu). The device was stored, handled and prepped as per ifu. The device was prepped normally (i. E. Maintained negative pressure). There was little tortuosity noted on the vessel. It had 90% stenosis. The device was not used for a chronic total occlusion. There was no difficulty in removing the stylet or any sterile packaging components. There was no difficulty in removing product from the hoop. There was no difficulty in removing the protective balloon cover. There were no kinks or other damages noted prior to inserting the product into the patient. A non-cordis contrast media was used and the contrast to saline ratio is 50/50. They used a non-cordis inflation device (indeflator/syringe) and the same indeflator was used successfully with other devices. There was no resistance/friction felt while inserting the balloon through the rotating hemostatic valve. There was no resistance/friction felt when inserting the balloon through the guide catheter. There was no unusual force used at any time during the procedure. The device was removed intact (in one piece) from the patient. The balloon was delivered to the target lesion without incident and there was no visible calcium. The balloon was removed from the patient without complication. The procedure was completed using a new balloon catheter. Other additional procedural details were requested but were unknown.

 
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Brand NameSABER 4MM30CM 150
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 Key9458777
MDR Text Key175896290
Report Number9616099-2019-03400
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK971010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/06/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/12/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number48004030X
Device LOT Number82163369
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 Received12/12/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/24/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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