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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CLEARSTREAM TECHNOLOGIES LTD. LIFESTREAM; BALLOON EXPANDABLE VASCULAR COVERED STENT
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CLEARSTREAM TECHNOLOGIES LTD. LIFESTREAM; BALLOON EXPANDABLE VASCULAR COVERED STENT Back to Search Results
Catalog Number LSM1350858
Device Problem Deflation Problem (1149)
Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/30/2021
Event Type  Injury  
Manufacturer Narrative
The catalog number identified has not been cleared in the us but is similar to the lifestream products that are cleared in the us.The pro code and 510 k number for the lifestream products are identified.As the lot number for the device was provided, a review of the device history records 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:11/2023).
 
Event Description
It was reported that during stent deployment procedure, the balloon allegedly failed to deflate.It was further reported that physician used plastipack syringe used to deflate the balloon.Patient reported stable.
 
Manufacturer Narrative
H10: manufacturing review: a complaint history review was performed.This is the second complaint reported for this product/lot number combination.The device history record review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the sample was returned for evaluation.The result of the investigation is unconfirmed for the reported balloon deflation issue.During the evaluation of the returned device after inflation with water to 6atm the balloon deflated successfully without issue.The root cause for the reported deflation issue could not be determined based upon the available information received from the field communication.Labeling review: the instructions for use for the lifestream product was reviewed and contains the following information relevant to the reported event: warnings: do not retract the balloon until the balloon is fully deflated under vacuum.Slowly inflate the endovascular system balloon to nominal pressure, expanding the covered stent.Confirm complete expansion via fluoroscopic visualization.A 15 ¿ 30 second inflation time is recommended.Important: do not exceed the rated burst pressure of the delivery system.After covered stent deployment, apply negative pressure to the balloon until it is fully deflated.Withdraw the delivery system while maintaining negative pressure with the guidewire remaining across the lesion.H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the lifestream products that are cleared in the us.The pro code and 510 k number for the lifestream products are identified in d2 and g4.H10: d4 (expiry date: 11/2023).H11:section a through f - the information provided by bd 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 bd.
 
Event Description
It was reported that during stent deployment procedure, the balloon allegedly failed to deflate.It was further reported that physician used plastipack syringe used to deflate the balloon.Patient reported to be stable.
 
Manufacturer Narrative
H10: manufacturing review: a complaint history review was performed.This is the second complaint reported for this product/lot number combination.The device history record review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the sample was returned for evaluation.The result of the investigation is unconfirmed for the reported balloon deflation issue.During the evaluation of the returned device after inflation with water to 6atm the balloon deflated successfully without issue.The root cause for the reported deflation issue could not be determined based upon the available information received from the field communication and sample evaluation.Labeling review: the instructions for use for the lifestream product was reviewed and contains the following information relevant to the reported event: warnings ¿ do not retract the balloon until the balloon is fully deflated under vacuum.15.Slowly inflate the endovascular system balloon to nominal pressure, expanding the covered stent.Confirm complete expansion via fluoroscopic visualization.A 15 ¿ 30 second inflation time is recommended.Important: do not exceed the rated burst pressure of the delivery system.16.After covered stent deployment, apply negative pressure to the balloon until it is fully deflated.Withdraw the delivery system while maintaining negative pressure with the guidewire remaining across the lesion.H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the lifestream products that are cleared in the us.The pro code and 510 k number for the lifestream products are identified in d2 and g4.H10: d4 (expiry date:11/2023), h11: h6 (method, result and conclusion).H11: section a through f: the information provide by bd represents all 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 bd.H3 other text : see h10.
 
Event Description
It was reported that during stent deployment procedure, the balloon allegedly failed to deflate.It was further reported that physician used plastipack syringe to deflate the balloon.Patient reported stable.
 
Manufacturer Narrative
H10: manufacturing review: a complaint history review was performed.This is the second complaint reported for this product/lot number combination.The device history record review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the sample was returned for evaluation.The result of the investigation is unconfirmed for the reported balloon deflation issue.During the evaluation of the returned device after inflation with water to 6atm the balloon deflated successfully without issue.The root cause for the reported deflation issue could not be determined based upon the available information received from the field communication.Labeling review: the instructions for use for the lifestream product was reviewed and contains the following information relevant to the reported event: warnings ¿ do not retract the balloon until the balloon is fully deflated under vacuum.15.Slowly inflate the endovascular system balloon to nominal pressure, expanding the covered stent.Confirm complete expansion via fluoroscopic visualization.A 15 ¿ 30 second inflation time is recommended.Important: do not exceed the rated burst pressure of the delivery system.16.After covered stent deployment, apply negative pressure to the balloon until it is fully deflated.Withdraw the delivery system while maintaining negative pressure with the guidewire remaining across the lesion.H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the lifestream products that are cleared in the us.The pro code and 510 k number for the lifestream products are identified in d2 and g4.H10: d4 (expiry date: 11/2023),.
 
Event Description
It was reported that during stent deployment procedure, the balloon allegedly failed to deflate.It was further reported that physician used plastipack syringe used to deflate the balloon.Patient reported to be stable.
 
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Brand Name
LIFESTREAM
Type of Device
BALLOON EXPANDABLE VASCULAR COVERED STENT
Manufacturer (Section D)
CLEARSTREAM TECHNOLOGIES LTD.
moyne upper
enniscorthy, co. wexford N A
EI  N A
MDR Report Key11730468
MDR Text Key247479734
Report Number9616666-2021-00056
Device Sequence Number1
Product Code PRL
Combination Product (y/n)N
PMA/PMN Number
P160024
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup,Followup
Report Date 09/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberLSM1350858
Device Lot NumberCMEZ0338
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/21/2021
Date Manufacturer Received09/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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