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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL SABER RX8MM4CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CASHEL SABER RX8MM4CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 51008004L
Device Problems Detachment Of Device Component; Crack; Difficult To Position; Catheter; Tip
Event Date 10/10/2017
Event Type  Malfunction  
Manufacturer Narrative

Device history record (dhr) review was conducted and the product met quality requirements for product acceptance. This device was received for analysis but the engineering report is not yet available. However, it will be submitted within 30 days upon receipt.

 
Event Description

It was reported that the saber balloon catheter was inserted, however, the balloon catheter was caught by the calcification and could not cross the lesion. Once the saber balloon was removed from the patient, it was confirmed that the tip was fractured. The saber balloon was replaced with another unknown balloon and the procedure was completed successfully. There was no patient injury. The target lesion was the iliac artery. The patient¿s vessel level of tortuosity was unknown. The lesion was calcified. The rate of stenosis was unknown. The product was clinically used and will be returned for analysis.

 
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Brand NameSABER RX8MM4CM155
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
CORDIS CASHEL
cahir road
cashel, tipperary
EI 
Manufacturer (Section G)
CORDIS CASHEL
cahir road
cashel, tipperary
EI 
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes , FL 33014
MDR Report Key7005798
Report Number9616099-2017-01557
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 02/14/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/07/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/28/2019
Device MODEL Number51008004L
Device Catalogue Number51008004L
Device LOT Number17449264
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/14/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date10/11/2017
Event Location No Information
Date Manufacturer Received01/25/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/11/2016
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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