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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL SABER 3MM15CM 150 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CASHEL SABER 3MM15CM 150 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 48003015X
Device Problems Partial Blockage; Catheter
Event Date 09/13/2018
Event Type  Malfunction  
Manufacturer Narrative

A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan. This device was received for analysis but the engineering report is not yet available. However, it will be submitted within 30 days upon receipt.

 
Event Description

During use in patient, it was reported that the guide wire cannot pass through the saber balloon delivery cavity, which seems to be blocked by the delivery cavity. During analysis of the device, a cross-section cutting procedure was performed and a foreign material was detected that impeded the travel of the guide wire into the lumen. There was no patient injury. The same wire was used with another catheter to complete the procedure. There were no difficulties removing the product from the hoop, the protective balloon cover, the stylet or any of the sterile packaging components. There were no kinks or other damages noted prior to inserting the product the product into the patient. The product was inspected prior to use and appeared to be normal. The device was prepped properly according to the instructions for use (ifu). There were no difficulties reported flushing the balloon catheter prior to use. There were no problems noted during prep. A non-cordis guidewire was used with the saber balloon. Additional procedural details were requested but are unknown.

 
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Brand NameSABER 3MM15CM 150
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
CORDIS CASHEL
cahir road
cashel, tipperary 0000
EI  0000
Manufacturer (Section G)
CORDIS CASHEL
cahir road
cashel, tipperary 0000
EI  0000
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes , FL 33014
7863138372
MDR Report Key8197405
Report Number9616099-2018-02600
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type FOREIGN
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/02/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/26/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number48003015X
Device Catalogue Number48003015X
Device LOT Number17685131
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/03/2018
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/27/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/15/2017
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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