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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL SABER 5MM8CM 90 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CASHEL SABER 5MM8CM 90 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number 48005008S
Device Problems Detachment Of Device Component; Catheter; Tip
Event Date 01/04/2018
Event Type  Malfunction  
Manufacturer Narrative

Manufacturing record (dhr) review was conducted and the product met quality requirements for product acceptance per the applicable manufacturing quality plan. The product was returned for evaluation and testing; however, the engineering evaluation is not complete. Additional information will be submitted within 30 days upon receipt.

 
Event Description

The report received indicated that the 90 cm. Saber 5 mm. X 8 cm. Balloon catheter (bc) was loaded onto an unknown guidewire. As the bc was advanced over the guidewire towards the sheath it was noted that the tip of the balloon shaft had disconnect from the shoulders of the balloon. The product/ whole device was removed. There was no reported patient injury.

 
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Brand NameSABER 5MM8CM 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 Key7244048
Report Number9616099-2018-01828
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 03/07/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/06/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/31/2019
Device Catalogue Number48005008S
Device LOT Number17429723
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/25/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date01/09/2018
Event Location No Information
Date Manufacturer Received03/02/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/18/2016
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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