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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL SABER 3MM25CM 150 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CASHEL SABER 3MM25CM 150 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 48003025X
Device Problems Partial Blockage; Catheter
Event Date 04/01/2019
Event Type  Malfunction  
Manufacturer Narrative

A device history record (dhr) review of lot 17700748 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with 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 3mm x 25cm 150 percutaneous transluminal angioplasty (pta) balloon catheter (bc) could not be flushed with heparinized saline. The guidewire could not pass through the balloon and the guidewire was used to pass through a white foreign body about 1cm long. There was no reported patient injury. The lesion was calcified. There was not any vessel angulation. The device was not being used to treat chronic total occlusion (cto). The target lesion was the anterior tibial artery. A contralateral approach was not used. The device did not kink or bend at any time prior to the resistance or friction. The same guidewire was used to complete the procedure. The other devices used with the product did not kink or bend at any time. The blockage caused by the material could not be inserted into the patient and cause harm to the patient. The procedure was completed with a non-cordis balloon.

 
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Brand NameSABER 3MM25CM 150
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
CORDIS CASHEL
cahir road
cashel, co. tipperary
EI 
Manufacturer (Section G)
CORDIS CASHEL
cahir road
cashel, co. tipperary
EI 
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes , FL 33014
7863138372
MDR Report Key8565091
Report Number9616099-2019-02884
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 06/04/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/30/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number48003025X
Device Catalogue Number48003025X
Device LOT Number17700748
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/24/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/01/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/27/2017
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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