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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS DE MEXICO SABER 2MM2CM 90 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS DE MEXICO SABER 2MM2CM 90 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number 48002002S
Device Problems Balloon; Material Frayed; Torn Material
Event Date 09/27/2017
Event Type  Malfunction  
Manufacturer Narrative

A review of the manufacturing documentation associated with this lot # 17526104 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, a saber 2mmx2cm 90 balloon was unable to be inflated. A slit on the balloon was confirmed. There was no reported patient injury. The patient¿s information was unknown. The target lesion was unknown. The patient¿s vessel level of tortuosity and calcification was unknown. The rate of stenosis was unknown. The device was stored and handled per the instructions for use (ifu). There were no anomalies noted to the device when it was taken out of the packaging. There were no difficulties removing the product from the packaging, stylet or any of the sterile packaging components, the product from the hoop, or the protective balloon cover. The product was inspected prior to use and appear to be normal. The device was prepped per the ifu and prepped normally (i. E. Maintain negative pressure). There were no kinks or other damages noted prior to inserting the product into the patient. It is unknown how the procedure completed however, the procedure was finished successfully. The product removed intact (in one piece) from the patient. The device will be returned for analysis. Additional procedural details were requested but are unknown.

 
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Brand NameSABER 2MM2CM 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
karla castro
14201 nw 60th ave
miami lakes , FL 33014
MDR Report Key6967788
Report Number9616099-2017-01518
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 11/06/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/22/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/31/2019
Device Catalogue Number48002002S
Device LOT Number17526104
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/09/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/26/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/30/2016
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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