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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 48512025
Device Problems Leak/Splash (1354); Material Rupture (1546); Failure to Advance (2524); Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/23/2021
Event Type  malfunction  
Event Description
It was reported that during an angioplasty procedure to treat the lower extremity via the right superficial arterial occlusion, resistance was allegedly felt when the device was passed. It was further reported that the device was noted to be leaking contrast when the pressure reached 6 atm. The procedure was completed using another device. There was no reported patient injury.
 
Manufacturer Narrative
The catalog number identified has not been cleared in the us, but is similar to the savvy long otw pta catheter product that is in the us. The pro code and 510 k number for the savvy long otw pta catheter product is identified. Manufacturing review: a complaint history review was performed. This is the first complaint reported for this product/lot number combination. However, a device history records were reviewed and there was nothing found to indicate there was a manufacturing related cause for this event. Investigation summary: the sample was returned for evaluation. Videos were provided for review. The balloon was inflated with water but failed to maintain pressure due to a pinhole leak located at the distal marker band. The patency of the returned bantam device was performed using an inhouse 0. 018¿ guidewire without any issue. The result of the investigation is unconfirmed for the reported device incompatibility issue. The result of the investigation is confirmed for the reported leak issue. The result of the investigation is inconclusive for the failure to advance issue. The root cause for the reported leak, device incompatibility and failure to advance issues could not be determined based upon the available information received from the field communications and device review. Labeling review: the instruction for use for the bantam pta balloon catheter was reviewed and contains the following information relevant to the reported event: warnings: use a 20 ml or larger syringe for inflation. Use the catheter prior to the ¿use by¿ date specified on the package. Do not advance the guidewire, balloon dilation catheter, or any component if resistance is met, without first determining the cause and taking remedial action. This catheter is not recommended for pressure measurement or fluid injection. Precautions: carefully inspect the catheter prior to use to verify that catheter has not been damaged during shipment and that its size, shape and condition are suitable for the procedure for which it is to be used. Do not use if product damage is evident. If resistance is felt upon removal, then the balloon, guidewire and the sheath should be removed together as a unit, particularly if balloon rupture or leakage is known or suspected. This may be accomplished by firmly grasping the balloon catheter and sheath as a unit and withdrawing both together, using a gently twisting motion combined with traction. Proper functioning of the catheter depends on its integrity. Care should be used when handling the catheter. Damage may result from kinking, stretching, or forceful wiping of the catheter. Do not continue to use the balloon catheter if the shaft has been bent or kinked. 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. 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. (expiry date: 12/2023).
 
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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 Key13720266
MDR Text Key287554792
Report Number9616666-2022-00044
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 Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 02/11/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/10/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number48512025
Device Lot NumberCMFN0145
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/06/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/10/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/12/2021
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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