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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS DE MEXICO SABER 6MM20CM 90 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS DE MEXICO SABER 6MM20CM 90 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 48006020S
Device Problems Detachment Of Device Component (1104); Tip (3123)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/23/2017
Event Type  Malfunction  
Manufacturer Narrative

As reported upon opening, the tip of the saber 6mm 2mm 90 was found broken (the tip was found separated). The product was stored and handled according to the instructions for use (ifu). There was no damage noted to the packaging of the device. There were no difficulty removing the product from the package. The devices stored in the lab in its original packaging and the product was stored for 2-3 days before being distributed to the cath lab. The device was not returned for analysis. A device history record (dhr) review of lot 17051823 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¿ could not be confirmed as the device was not returned for analysis. The exact cause could not be determined. Based on the limited information provided, procedural/handling may have contributed to the reported event. According to the instructions for use (ifu), ¿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 nor the information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken.

 
Event Description

As reported upon opening, the tip of the saber 6mm 2mm 90 was found broken (the tip was found separated). The product was stored and handled according to the instructions for use (ifu). There was no damage noted to the packaging of the device. There were no difficulty removing the product from the package. The devices stored in the lab in it's original packaging and the product was stored for 2-3 days before being distributed to the cath lab.  the product will be returned for analysis.

 
Manufacturer Narrative

As reported upon opening, the tip of the saber 6mm 2mm 90 was found broken (the tip was found separated). The product was stored and handled according to the instructions for use (ifu). There was no damage noted to the packaging of the device. There were no difficulty removing the product from the package. The devices stored in the lab in its original packaging and the product was stored for 2-3 days before being distributed to the cath lab.   one non-sterile unit of saber 6mm 20cm 90 was received coiled inside a plastic. Per visual analysis the catheter distal tip was received separated, the distal separated section was not received. No other anomalies or damages were observed. Sem analysis was performed to identify the root cause of the catheter distal tip separation and results showed that the separated area presented elongations and frayed edges. These characteristics presented evidence of an application of a tension force that induced the separation. No other issues were noted during the sem analysis. A device history record (dhr) review of lot 17051823 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 analysis of the returned device. However, the exact cause of the reported failure could not be conclusively determined during analysis. Based on the limited information provided, procedural/handling may have contributed to the reported event as evidenced by the presence of elongations and frayed edges at the separated area during sem analysis. According to the instructions for use (ifu), which is not intended as a mitigation, ¿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 design or manufacturing process of the product. Therefore, no corrective/preventive action will be taken at this time.

 
Manufacturer Narrative

This device was received for analysis but the engineering report is not yet available.   however, it will be submitted within 30 days upon receipt.

 
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Brand NameSABER 6MM20CM 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, FL 33014
MDR Report Key6513718
MDR Text Key73455598
Report Number9616099-2017-01052
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeSN
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,Followup
Report Date 07/27/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/22/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/30/2017
Device MODEL Number48006020S
Device Catalogue Number48006020S
Device LOT Number17051823
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/26/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date04/14/2017
Event Location No Information
Date Manufacturer Received07/21/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/22/2014
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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