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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL SLALOM PTA .018 HP 40 3X4 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CASHEL SLALOM PTA .018 HP 40 3X4 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number 4393040T
Device Problems Crack (1135); Catheter (3038)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/26/2019
Event Type  Malfunction  
Manufacturer Narrative

A review of the manufacturing documentation associated with lot (17728332) 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 slalom thrill pta balloon catheter (. 018 hp 40 3x4) was used without any problems at the procedure. However, after the procedure, it was confirmed that the tip was about to come off. There was no reported patient injury. This was shunt percutaneous transluminal angioplasty case. The device was stored and handled per the instructions for use (ifu). There was no damage noted to the inner 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. The device was prepped according to instructions for use (ifu). There were no anomalies noted during or after the device was prepped. There were no kinks or other damages noted prior to inserting the product into the patient. There was no resistance advancing the device. There were no kink/bent noted after device was removed from patient. There was no unusual force used at any time during the procedure. There was no part of the device that fractured nor separated inside the patient body. There was no part of the device that migrated inside the patient¿s body. The device was removed intact (in one piece) from the patient. There was no patient injury. There is no procedural film/cd available for review. The device will be returned for analysis.

 
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Brand NameSLALOM PTA .018 HP 40 3X4
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 Key9115424
MDR Text Key160044116
Report Number9616099-2019-03222
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK003159
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 10/17/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/25/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/30/2020
Device Catalogue Number4393040T
Device LOT Number17728332
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/11/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/14/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/25/2017
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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