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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CLEARSTREAM TECHNOLOGIES LTD. BANTAM OTW PTA CATHETER PTA BALLOON DILATATION CATHETER

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CLEARSTREAM TECHNOLOGIES LTD. BANTAM OTW PTA CATHETER PTA BALLOON DILATATION CATHETER Back to Search Results
Catalog Number 48515025
Device Problems Device-Device Incompatibility (2919); Difficult to Advance (2920); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/17/2021
Event Type  malfunction  
Manufacturer Narrative
Manufacturing review: a complaint history review was performed. This is the first complaint reported for this lot number. A device history record review was performed and the lot met all release criteria. Investigation summary: the device was returned for evaluation. The result of the investigation is confirmed for the reported difficult to advance and device incompatibility issue. A video was also provided for review. The definitive root cause for the reported difficult to advance and device incompatibility issue could not be determined based upon the available information. Labeling review: the instructions for use for the bantam pta balloon catheter was reviewed and contains the following information relevant to the reported event: directions for use: inspection and preparation: remove the protective sheath by first withdrawing the stylet and then slowly removing the sheath while holding the catheter as close to the balloon as possible. If any resistance is felt, or if any stretching of the catheter is observed while removing the protective sheath, the product should not be used. The catheter should then be inspected for bends, kinks or stretched portions. Do not use if product damage is evident. Prepare a mixture of contrast medium and normal saline as per normal procedure. (recommended 25% /75%). Attach a stopcock and a 20 ml syringe half filled with the contrast solution to the balloon port. Point the syringe nozzle downward and aspirate until all air is removed from the balloon. Turn the stopcock off and maintain the vacuum in the balloon. Purge the catheter guidewire lumen thoroughly. Reinserting the balloon into the protective sheath may damage the balloon or catheter. Insertion and inflation note: do not advance the guidewire, balloon dilation catheter, or any component if resistance is met, without first determining the cause and taking remedial action. Note: do not inflate the balloon or advance the catheter unless the guidewire is in place. Make sure that the protective sheath has been removed from the dilation catheter balloon. Enter the vessel percutaneously using the standard seldinger technique over the appropriate guidewire for the size catheter being used. Advance the catheter across the lesion with fluoroscopic guidance using accepted percutaneous transluminal angioplasty technique and inflate the balloon to the appropriate pressure. Note: do not exceed the rated burst pressure. (expiry date: 10/2023).
 
Event Description
It was reported that during preparation of a procedure, the guidewire allegedly could not pass. The procedure was completed using another device. There was no patient contact.
 
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Brand NameBANTAM OTW PTA CATHETER
Type of DevicePTA BALLOON DILATATION CATHETER
Manufacturer (Section D)
CLEARSTREAM TECHNOLOGIES LTD.
moyne upper
enniscorthy, co. wexford N A
EI N A
Manufacturer (Section G)
CLEARSTREAM TECHNOLOGIES LTD.
moyne upper
enniscorthy, co. wexford N A
EI N A
Manufacturer Contact
judy ludwig
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key12679204
MDR Text Key277899674
Report Number9616666-2021-00173
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K072947
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/23/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number48515025
Device Lot NumberCMEY0028
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/23/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/23/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/03/2020
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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