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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 48522040
Device Problems Inflation Problem (1310); Peeled/Delaminated (1454); Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/13/2021
Event Type  malfunction  
Manufacturer Narrative
Manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing. This lot met all release criteria. There was nothing found to indicate there was a manufacturing related cause for this event. Investigation summary: the sample was returned for evaluation with the guidewire was not returned. The result of the investigation is inconclusive for the reported inflation issue. The balloon of the returned device was inflated successfully with water and maintained pressure at 6atm. Prior to the inflation attempt a twist in the balloon was confirmed 85mm from the distal tip. When inflated there was some evidence of minor creases at the twist location. When the balloon was deflated the twist was not apparent. The patency of the bantam device was performed using an inhouse 0. 018¿ guidewire but was not successful. The guidewire encountered a blockage between the proximal marker band and the balloon cone. The blockage was due to inner delamination in this area. The definitive root cause for the reported inflation 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: balloon characteristics individual compliance charts are provided on the package label of each product. Please note that balloon diameters may vary within manufacturing tolerances. All inflations should be viewed under fluoroscopy. The bantam¿ balloons reach their nominal diameter at 6 atm (608 kpa). Please check the package label for the rated burst pressure. It is important that the balloon not be inflated beyond the rated burst pressure. Pressures in excess of rated burst pressure may cause the balloon to burst. Warnings: use a 20 ml or larger syringe for inflation. 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: 06/2022).
 
Event Description
It was reported that during an angioplasty procedure, the device allegedly had inflation issue. There was another device used to complete the procedure. There was no reported patient injury.
 
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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 Key12679058
MDR Text Key278164073
Report Number9616666-2021-00170
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
Report Date 10/18/2021
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 Number48522040
Device Lot NumberCMDU0014
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/22/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/14/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/02/2019
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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