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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CLEARSTREAM TECHNOLOGIES LTD SLEEK OTW 3.0X4 X 150 SHAFT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CLEARSTREAM TECHNOLOGIES LTD SLEEK OTW 3.0X4 X 150 SHAFT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 4263004X
Device Problem Deflation Problem (1149)
Patient Problem No Code Available (3191)
Event Date 12/27/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
As reported, upon attempt to remove the sleek percutaneous transluminal angioplasty (pta) balloon catheter, the balloon could not be removed. With work, the balloon was able to be removed from the patient. The first attempt to deflate, the balloon did not deflate at all. Subsequent attempts resulted in partial deflation. A small enough amount was able to be aspirated with a 10ml syringe that the balloon could be removed partially deflated and partially inflated. After removal from the patient, it would not deflate even after multiple attempts. The balloon was not able to be properly deflated. There was vasospasm noted and treated with nitro but there was no harm to the patient. Upon attempt to inflate the balloon, the balloon was not visualized. There was no indication the balloon inflated normally. Negative was pulled on the balloon. The intended treatment site was the tibial. There was a little vessel tortuosity. There was 70% stenosis. The intended procedure was a percutaneous transluminal angioplasty (pta). The product was stored and handled according to the instructions for use (ifu). The product was inspected and prepped according to the ifu. The device did prep normally. There was no difficulty removing the product from the hoop. There was no difficulty removing the protective balloon cover. There was no difficulty removing the stylet or any of the sterile packaging components. There were no kinks or other damages noted prior to inserting he product into the patient. The product was not opened in sterile field. Per the customer, the balloon was tracked and placed easily. According to the customer, contrast/ saline mixture was used. The contrast to saline ratio was 50/50. The contrast media used was omnipaque 300. The balloon was inflated once. A non-cordis inflation device, sheath, and guidewire were used. The same indeflator was used successfully with other devices. There were no stents present within the treatment site or tracking path. There was no unusual force used at any time during the procedure. The catheter was never in any acute bend. The procedure was completed successfully. The product was removed intact (in one piece) from the patient.
 
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Brand NameSLEEK OTW 3.0X4 X 150 SHAFT
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
CLEARSTREAM TECHNOLOGIES LTD
enniscorthy
co. wexford
EI
MDR Report Key8335004
MDR Text Key136003803
Report Number1016427-2019-02511
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
PMA/PMN Number
K102035
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/24/2019,02/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/13/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2021
Device Model Number4263004X
Device Catalogue Number4263004X
Device Lot NumberCMCT0049
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/08/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/24/2019
Distributor Facility Aware Date01/14/2019
Event Location Hospital
Date Report to Manufacturer02/13/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 02/13/2019 Patient Sequence Number: 1
Treatment
COOK 6FR SHEATH; ENCORE INDEFLATOR; GRAND SLAM .014 GUIDEWIRE; NITRO
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