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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL POWERFLEX EXTREME 6X4 80CM CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CASHEL POWERFLEX EXTREME 6X4 80CM CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 4156040S
Device Problems Shaft; Leak / Splash
Event Date 05/03/2019
Event Type  Malfunction  
Manufacturer Narrative

This device is available for analysis but has not yet been received. Additional information is pending and will be submitted within 30 days upon receipt.

 
Event Description

As reported, a powerflex extreme 6x4 80cm percutaneous transluminal angioplasty (pta) balloon catheter (bc) sprayed contrast/saline from an area near the hub. There was no reported patient injury. The balloon was initially placed in the cephalic vein and inflated three times to rated burst pressure (rbp) 20 atmospheres (atm) for pre-dilatation prior to stent placement. The initial delivery, inflations and removal of the balloon were performed without incident. After stent placement, the balloon was delivered once more for post-dilatation. During the attempt at inflation, an undetermined area in the vicinity of the hub of the balloon sprayed contrast/saline into the face and eyes of the physician. The physician broke scrub and rinsed his eyes and face at a nearby eyewash station and returned to complete the case. The target lesion was focal stenosis. There was not any calcification. There was not any vessel tortuosity. There was not any vessel angulation. The device was not being used to treat chronic total occlusion (cto). There was not any difficulty removing the product from the hoop. There was not any difficulty removing the protective balloon cover. There was not any difficulty removing the stylet or any of the sterile packaging components. Kinks or other damages were not noted prior to inserting the product into the patient. There was not any resistance or friction while inserting the balloon through the rotating hemostatic valve. There was not any resistance or friction while inserting the balloon through the guide catheter.

 
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Brand NamePOWERFLEX EXTREME 6X4 80CM
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 Key8658568
Report Number9616099-2019-02986
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 06/24/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/31/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number4156040S
Device Catalogue Number4156040S
Device LOT Number82159250
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/03/2019
Was Device Evaluated By Manufacturer? No
Date Device Manufactured09/08/2018
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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