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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS DE MEXICO SABER 4MM20CM 90 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS DE MEXICO SABER 4MM20CM 90 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 48004020S
Device Problems Detachment Of Device Component (1104); Tip (3123)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/13/2017
Event Type  Malfunction  
Manufacturer Narrative

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

It was reported that the saber balloon catheter tip came off during preparation. A new saver balloon catheter was used to complete the procedure. There was no patient injury. There was no damages noted to the device packaging. There was no force used when the device was removed from the packaging. There was no difficulty removing the product from the hoop, the protective balloon cover, the stylet or any of the sterile packaging components.

 
Manufacturer Narrative

During preparation, a 4x200mm saber balloon catheter tip came off. A new saber balloon catheter was used to complete the procedure. There was no patient injury. There was no damages noted to the device packaging. There was no force used when the device was removed from the packaging. There was no difficulty removing the product from the hoop, the protective balloon cover, the stylet or any of the sterile packaging components. One non-sterile unit of saber 4mm20cm 90 was received coiled inside a plastic bag. Per visual analysis, the balloon was previously inflated/deflated, the distal tip of the balloon device was found separated. No damages were noted in the device. The separated tip was inspected under microscope and it was noticed that the separated edges presented evidence of elongation. Unit was sent to sem analysis and results showed that the distal and proximal sections of the separated tip presented evidence of elongations. The elongations observed suggests that the device was induced to stretching/pulling events that exceeded the material¿s yield strength prior to the separation. No other issues were noted during sem analysis. A device history record (dhr) review of lot 17483975 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event. The reported ¿distal tip - separated - during prep¿ was confirmed through product analysis. However, the exact root cause of the separated condition could not be conclusively determined. Based on the information available for review, procedural/handling factors may have contributed to the event reported as evidenced by elongations found during sem analysis. According to the instructions for use ¿if resistance is felt upon removal, then the balloon, guidewire and the sheath should be removed together as a unit, particularly if balloon rupture or leakage is known or suspected. Proper functioning of the catheter depends on its integrity. Care should be used when handling the catheter. Damage may result from kinking, stretching, or forceful wiping of the catheter. Forceful handling can result in catheter separation and the subsequent need to use a snare or other medical interventional techniques to retrieve the pieces. Always verify integrity of the catheter after removal. ¿ neither the dhr review nor the product analysis suggests that the event experienced by the customer could be related to the manufacturing process. Therefore, no corrective and preventive actions will be taken at this time.

 
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Brand NameSABER 4MM20CM 90
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
CORDIS DE MEXICO
circuito int nte 1820
juarez 32575
MX 32575
Manufacturer (Section G)
CORDIS DE MEXICO
circuito int nte 1820
juarez 32575
MX 32575
Manufacturer Contact
cecil navajas
14201 nw 60th avenue
miami lakes, FL 33014
MDR Report Key6471849
MDR Text Key72230621
Report Number9616099-2017-01027
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeGM
PMA/PMN NumberK971010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 04/20/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/07/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/30/2019
Device MODEL Number48004020S
Device Catalogue Number48004020S
Device LOT Number17483975
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/20/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date03/14/2017
Event Location No Information
Date Manufacturer Received04/11/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/25/2016
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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