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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CLEARSTREAM TECHNOLOGIES LTD. SAVVY LONG OTW PTA CATHETER; PTA BALLOON DILATATION CATHETER
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CLEARSTREAM TECHNOLOGIES LTD. SAVVY LONG OTW PTA CATHETER; PTA BALLOON DILATATION CATHETER Back to Search Results
Model Number 436-2522L
Device Problems Break (1069); Detachment of Device or Device Component (2907); Packaging Problem (3007)
Patient Problem No Patient Involvement (2645)
Event Date 08/06/2018
Event Type  malfunction  
Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.Expiry date: nov / 2019.
 
Event Description
It was reported that during preparation, a break on the pta balloon catheter was allegedly identified.It was further reported that the protective sleeve on the balloon could not be removed without further damage to the balloon.There was no patient contact.
 
Event Description
It was reported that during preparation, a break on the pta balloon catheter was allegedly identified.It was further reported that the protective sleeve on the balloon could not be removed without further damage to the balloon.There was no patient contact.
 
Manufacturer Narrative
H10: manufacturing review: the production history for the device, was reviewed and no anomalies were identified.The lot met all test release criteria.Nothing was found to indicate a manufacturing related cause for this event.This is the first reported complaint for this lot number and issue to date.Investigation summary: the result of the investigation is unconfirmed for the break failure mode reported.However a detachment was observed, the balloon was detached from the outer at the proximal bond.The inner was also stretched in the detachment area.The sleeve was easily removed during the evaluation.The definitive root cause for the break issue could not be determined based upon available information.The manufacturing documentation was reviewed and shows no anomalies with the manufacture of this lot to suggest a product issue.It is unknown whether handling or procedural techniques during device preparation contributed to the reported event.Labeling review: the ifu for the savvy long product (in096 rev 05) was reviewed and contains the following information relevant to the reported event: precautions: ¿ carefully inspect the catheter prior to use to verify that the 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.Directions for use: inspection and preparation: note: a 0.018¿ (0.457 mm) guidewire must be inserted in the savvy® long catheter across the balloon during any inflation of the balloon.¿ remove the balloon sleeve by first withdrawing the shipping mandrel slightly and then slowly removing the sleeve 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 balloon sleeve, 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.H10: d4 - expiry date: nov / 2019; g4; h6 (device - 2976); h11: d10; e1; h3; h6 (method, results codes).
 
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Brand Name
SAVVY LONG OTW PTA CATHETER
Type of Device
PTA BALLOON DILATATION CATHETER
Manufacturer (Section D)
CLEARSTREAM TECHNOLOGIES LTD.
moyne upper
enniscorthy, co. wexford
EI 
MDR Report Key8067036
MDR Text Key127865328
Report Number9616666-2018-00160
Device Sequence Number1
Product Code LIT
UDI-Device Identifier00801741132865
UDI-Public(01)00801741132865
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,distri
Type of Report Initial,Followup
Report Date 12/20/2018
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 Health Professional
Device Model Number436-2522L
Device Catalogue Number436-2522L
Device Lot Number50146208
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/23/2018
Initial Date Manufacturer Received 10/17/2018
Initial Date FDA Received11/13/2018
Supplement Dates Manufacturer Received12/05/2018
Supplement Dates FDA Received12/20/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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