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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL SABER RX6MM2CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CASHEL SABER RX6MM2CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 51006002L
Device Problems Crack; Catheter
Event Date 02/02/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(6). Device history record (dhr) review was conducted and the product met quality requirements for product acceptance. This device is available for analysis but has not yet been received. Additional information is pending and will be submitted within 30 days upon receipt.

 
Event Description

During use, it was reported that the saber balloon catheter shaft was cracked after it was noted that pressure could not be applied. There was no patient injury. The saber balloon was replaced with a new saber balloon (different size) and the procedure completed successfully. The target lesion was unknown. The patient¿s vessel level of tortuousness and calcification was unknown. The rate of stenosis was unknown. The product was clinically used and will be returned for analysis.

 
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Brand NameSABER RX6MM2CM155
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 Key7299511
Report Number9616099-2018-01951
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 05/25/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/27/2018
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 Number51006002L
Device Catalogue Number51006002L
Device LOT Number17449265
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date02/02/2018
Event Location No Information
Date Manufacturer Received05/22/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/15/2016
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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