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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION SABER 5MM30CM 150 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CORPORATION SABER 5MM30CM 150 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 48005030X
Device Problems Crack (1135); Catheter (3038)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/22/2020
Event Type  Malfunction  
Manufacturer Narrative

A review of the manufacturing documentation associated with lot (17691860) presented no issues during the manufacturing process that can be related to the reported event. This device is available for analysis, but the engineering report is not yet available. However, it will be submitted within 30 days upon receipt.

 
Event Description

As reported, cracks in the ¿interface¿ of a 5mm x 30cm 150cm saber percutaneous transluminal angioplasty (pta) balloon catheter were found in preparation for the ¿second balloon filling¿. There was no reported patient injury. The user was trained with the device. The device was opened in the sterile field. The type of damage noted on the device that it was cracked. 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. There were no visible signs of device/package damage prior to use. There were no anomalies noted when the device was taken out of the package. There was no excessive force applied to the device during withdrawal from package. The integrity of the sterile pouch was not compromised. The device was not used in patient. The device will be returned for evaluation.

 
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Brand NameSABER 5MM30CM 150
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60th ave
miami lakes FL 33014
Manufacturer (Section G)
CORDIS CORPORATION
14201 nw 60th ave
miami lakes FL 33014
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
7863138372
MDR Report Key10296116
MDR Text Key199684624
Report Number9616099-2020-03792
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 FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 07/30/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/20/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/30/2020
Device MODEL Number48005030X
Device Catalogue Number48005030X
Device LOT Number17691860
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/10/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/24/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/05/2017
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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