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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL SABER RX5MM10CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CASHEL SABER RX5MM10CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number 51005010L
Device Problem Structural Problem (2506)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/17/2019
Event Type  malfunction  
Manufacturer Narrative
A review of the manufacturing documentation associated with lot (17565912) 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 saber rx pta balloon catheter (5mm10cm155) was attempted to be used during procedure; however, it was confirmed that the position of the proximal markers on the balloon proxy side was largely shifted. There was no reported patient injury. The lesion was the superficial femoral artery. The vessel level of angulation, calcification and tortuosity is none. The device was being used for treatment of a chronic total occlusion. Initially, an ipsilateral approach was made. The device damaged was noted during use. The device was stored and handled per the instructions for use (ifu). There was no damage noted to the package. The integrity of the sterile pouch was not compromised. There were no anomalies noted to the device when it was taken out of the packaging. There were no damages noted prior to inserting the product into the patient. The device was prepped according to instructions for use (ifu). The device was prep normally. The device was used in-patient. There was no difficulty advancing the balloon catheter through the vessel. The catheter was not torqued against resistance. There was no excessive torque used during advancement or delivery of the device. There was no unusual force used at any time during the procedure. There were no kink/bent noted after device was removed from patient. The device was removed intact (in one piece) from the patient. There was no other type of malfunction noted on the device. The device was removed, and the procedure was completed. The device will be returned for analysis.
 
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Brand NameSABER RX5MM10CM155
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 Key8862158
MDR Text Key197292054
Report Number9616099-2019-03120
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeJA
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 09/03/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/05/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2019
Device Catalogue Number51005010L
Device Lot Number17565912
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/15/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/20/2018
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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