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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS DE MEXICO SABER 5MM20CM 90 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS DE MEXICO SABER 5MM20CM 90 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 48005020S
Device Problems Detachment Of Device Component (1104); Catheter (3038); Tip (3123)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/28/2017
Event Type  Malfunction  
Manufacturer Narrative

Manufacturing record (dhr) review was conducted and the product met quality requirements for product acceptance per the applicable manufacturing quality plan.   the product is available for evaluation and testing. However, the product has not been returned as of to date. Additional information will be submitted within 30 days upon receipt.

 
Event Description

As reported, the tip of the 90 cm. Saber 5 mm. X 20 cm. Balloon catheter came away from the balloon. The product did not enter the patient. There was no reported patient injury. The product will be returned for inspection. Additional information received indicated that the reported event occurred during removal of the complaint product over the guidewire. There were no other product issues noted. The procedure was completed successfully without patient injury using other balloon catheters. The product was stored properly according to the instructions for use (ifu). There was no damage noted to the product packaging upon inspection prior to use. There was no reported difficulty removing the product from the packaging.

 
Manufacturer Narrative

Additional information: the product was returned for inspection. The product was returned for evaluation and testing; however, the engineering evaluation is not complete. Additional information will be submitted within 30 days upon receipt.

 
Manufacturer Narrative

Additional information received indicated that no additional intervention was necessary to remove the separated tip. The product was prepped properly according to the instructions for use (ifu) with no problems noted during preparation. There was no other product issue noted either at the account after the procedure or prior to shipping for inspection. No additional information is available. Additional information will be submitted within 30 days upon receipt.

 
Manufacturer Narrative

As reported, the tip of the 90 cm. Saber 5 mm. X 20 cm. Balloon catheter came away from the balloon. The product did not enter the patient. There was no reported patient injury. Additional information received indicated that the reported event occurred during removal of the complaint product over the guidewire. There were no other product issues noted. The procedure was completed successfully without patient injury using other balloon catheters. The product was stored properly according to the instructions for use (ifu). There was no damage noted to the product packaging upon inspection prior to use. There was no reported difficulty removing the product from the packaging. Additional information received indicated that no additional intervention was necessary to remove the separated tip. The product was prepped properly according to the instructions for use (ifu) with no problems noted during preparation. There was no other product issue noted either at the account after the procedure or prior to shipping for inspection. No additional information is available.   one non-sterile saber 5mm20cm 90 was received for analysis coiled inside a plastic bag. Per visual analysis, the tip of the balloon catheter was received within a small separated plastic bag. No other anomalies observed. Sem analysis was conducted and results showed that the separated sections at the distal tip 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 17477983 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 - in-patient¿ was confirmed based on product analysis. However, the exact cause of the separated condition could not be conclusively determined. Procedural/handling factors may have contributed to the event reported as evidenced by elongations and frayed edges 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 5MM20CM 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 ave.
miami lakes, FL 33014
MDR Report Key6420834
MDR Text Key70454427
Report Number9616099-2017-00985
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeUK
PMA/PMN NumberK971010
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,Followup,Followup
Report Date 04/20/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/21/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/31/2019
Device MODEL Number48005020S
Device Catalogue Number48005020S
Device LOT Number17477983
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/21/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date02/28/2017
Event Location No Information
Date Manufacturer Received04/17/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/20/2016
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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