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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL SABER 7MM6CM 90 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CASHEL SABER 7MM6CM 90 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number 48007006S
Device Problems Shaft; Leak / Splash; Catheter
Event Date 12/18/2018
Event Type  Malfunction  
Manufacturer Narrative

A review of the manufacturing documentation associated with lot 17539125 presented no issues during the manufacturing process that can be related to the reported event. 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, the shaft of a saber balloon catheter had a leak. There was no reported patient injury. The procedure was completed with another saber pta balloon catheter. There was no difficulty removing the product from the hoop or protective balloon cover. The device was prepped per the instructions for use. There was unusual force used during the procedure. Contrast leaked out of the catheter. The balloon was still able to be inflated, despite the leak in the catheter. There are no procedural films or cd¿s available for review. Additional procedural details were requested but are unknown.

 
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Brand NameSABER 7MM6CM 90
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
MDR Report Key8246168
Report Number9616099-2019-02635
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 02/07/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/14/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/30/2019
Device Catalogue Number48007006S
Device LOT Number17539125
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/03/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/18/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/15/2016
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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