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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CLEARSTREAM TECHNOLOGIES LTD. BANTAM OTW PTA DILATATION CATHETER
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CLEARSTREAM TECHNOLOGIES LTD. BANTAM OTW PTA DILATATION CATHETER Back to Search Results
Catalog Number 48522025
Device Problems Break (1069); Detachment of Device or Device Component (2907); Packaging Problem (3007)
Patient Problem No Patient Involvement (2645)
Event Date 03/19/2018
Event Type  malfunction  
Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The return of the device is pending.The investigation is currently underway.The catalog number identified in section has not been cleared in the us, but is similar to the savvy long pta dilatation catheter products that are cleared in the us.The 510 k number and pro code for the savvy long pta dilatation catheter products are identified.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
 
Event Description
It was reported that the balloon sleeve was allegedly unable to be removed and that as force was applied in an effort to remove the balloon sleeve one layer of the catheter shaft allegedly broke.Reportedly, the pta balloon catheter was unable to be used.There was no patient contact.
 
Event Description
It was reported that the balloon sleeve was allegedly unable to be removed and that as force was applied in an effort to remove the balloon sleeve one layer of the catheter shaft allegedly broke.Reportedly, the pta balloon catheter was unable to be used.There was no patient contact.
 
Manufacturer Narrative
The catalog number identified has not been cleared in the us, but is similar to the savvy long and the sleek pta dilatation catheter products that are cleared in the us.The 510 k number and pro code for the savvy long and the sleek pta dilatation catheter products are identified.Manufacturing review: the lot number was provided and the lot device history records have been reviewed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the investigation was unconfirmed for the reported packaging issue failure mode 'balloon sleeve was allegedly unable to be removed'.Although moderate difficulty was encountered during the sample evaluation, the sleeve was removed successfully.An indent was noted on the sleeve 46mm from the proximal end and this may have attributed to the resistance during the sleeve removal.The source of the indent is unknown but may have been caused when the original user was attempting to remove the sleeve.The evaluation also observed a detachment and kinks.The balloon was not attached to the outer catheter at the proximal bond and there were 3 kinks noted on the inner catheter at the area of detachment.It was reported 'that force was applied in an effort to remove the balloon sleeve'.It is likely that excessive force was used that resulted in the detachment.Based on the available information a definitive root cause has not been determined.Labeling review: the ifu for the bantam otw product was reviewed and contains the following information relevant to the reported event: a device description the bantam percutaneous transluminal angioplasty (pta) balloon catheters are non-reusable semi-compliant coaxial design catheters consisting of an over the wire (otw) catheter with a balloon mounted on its distal tip.The hub/"y" connector consists of a guidewire lumen, allowing the catheter to track over a guidewire, and a balloon port, used to inflate the balloon.Indication for use the bantam tm pta balloon catheters are intended for balloon dilation of renal, iliac and femoral arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.These catheters are not designed to be used in the coronary arteries.Directions for use inspection and preparation 1) 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.2) if any resistance is felt, or if any stretching of he catheter is observed while removing the protective sheath, the product should not be used.3) the catheter should then be inspected for bends, kinks or stretched portions.Do not use if product damage is evident.4) prepare a mixture of contrast medium and normal saline as per normal procedure.(recommended 25% / 75%.5) attach a stopcock and a 20ml syringe half filled with the contrast solution to the balloon port.6) point the syringe nozzle downward and aspirate until all air is removed from the balloon.7) turn the stopcock off and maintain the vacuum in the balloon.8) purge the catheter guidewire lumen thoroughly.9) reinserting the balloon into the protective sheath may damage the balloon or catheter.
 
Manufacturer Narrative
H10: manufacturing review: the lot number was provided and the lot device history records have been reviewed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint that has been reported for this corporate lot number to date.Investigation summary: the result of the investigation was inconclusive.The sample was not returned for evaluation.Based on the available information a definitive root cause has not been determined.It is unknown if handling or procedural techniques contributed to the reported event.Labeling review: the ifu for the bantam otw product was reviewed and contains the following information relevant to the reported event: a device description.The bantam percutaneous transluminal angioplasty (pta) balloon catheters are non-reusable semi-compliant coaxial design catheters consisting of an over the wire (otw) catheter with a balloon mounted on its distal tip.The hub/"y" connector consists of a guidewire lumen, allowing the catheter to track over a guidewire, and a balloon port, used to inflate the balloon.Indication for use: the bantam tm pta balloon catheters are intended for balloon dilation of renal, iliac and femoral arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.These catheters are not designed to be used in the coronary arteries.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 he 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 20ml 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.
 
Event Description
It was reported that the balloon sleeve was allegedly unable to be removed and that as force was applied in an effort to remove the balloon sleeve one layer of the catheter shaft allegedly broke.Reportedly, the pta balloon catheter was unable to be used.There was no patient contact.
 
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Brand Name
BANTAM OTW PTA DILATATION CATHETER
Type of Device
PTA DILATATION CATHETER
Manufacturer (Section D)
CLEARSTREAM TECHNOLOGIES LTD.
moyne upper
enniscorthy, co. wexford
EI 
MDR Report Key7472747
MDR Text Key107069857
Report Number9616666-2018-00048
Device Sequence Number1
Product Code LIT
UDI-Device Identifier05391515540637
UDI-Public(01)05391515540637
Combination Product (y/n)N
PMA/PMN Number
K072947
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 08/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date08/31/2019
Device Catalogue Number48522025
Device Lot NumberCMAW0206
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/21/2018
Initial Date Manufacturer Received 04/03/2018
Initial Date FDA Received04/30/2018
Supplement Dates Manufacturer Received06/06/2018
08/27/2018
Supplement Dates FDA Received06/25/2018
08/31/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age73 YR
Patient Weight65
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