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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL SABER 4MM15CM 150 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CASHEL SABER 4MM15CM 150 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number 48004015X
Device Problems Material Puncture/Hole (1504); Catheter (3038)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/04/2019
Event Type  Malfunction  
Manufacturer Narrative

A review of the manufacturing documentation associated with lot (17695249) presented no issues during the manufacturing process that can be related to the reported event. Additional information is pending and will be submitted within 30 days upon receipt.

 
Event Description

As reported, a 0. 018cm guidewire failed to go through the 4mm x 15cm x 150 saber balloon catheter after they both had been delivered to the lesion. Therefore, the saber was replaced with another balloon of the same balloon and the procedure was completed successfully. There was no reported patient injury. Initially, the lower extremity vein was opened and the guidewire crossed the lesion. The balloon was intended to be used to expand the lesion. The package of the balloon was not damaged. The package was opened, the balloon removed and the necessary steps for flushing and exhaust were made. Additional information was received after preliminary product evaluation, a. 018¿ guide wire sample was introduced into the guide wire lumen of the saber balloon via tip. The sample guide wire could not be advanced through the guide wire lumen due to a rupture in it.

 
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Brand NameSABER 4MM15CM 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 Key9267104
MDR Text Key198406776
Report Number9616099-2019-03317
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeCH
PMA/PMN NumberK971010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 11/07/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/01/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/30/2020
Device Catalogue Number48004015X
Device LOT Number17695249
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/16/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/04/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/14/2017
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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