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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 436-2515X
Device Problems Break (1069); Packaging Problem (3007)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/23/2020
Event Type  malfunction  
Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review will be performed. The return of the sample is pending. The investigation of the reported event is currently underway. 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. Device pending return.
 
Event Description
It was reported that prior to an angioplasty procedure the proximal catheter near the balloon was allegedly broken. It was further reported that the balloon protective cover allegedly difficult to be removed. The procedure was completed using another device. There was no reported patient contact.
 
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Brand NameSAVVY LONG 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 Key10704868
MDR Text Key212114458
Report Number9616666-2020-20007
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K072947
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 11/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number436-2515X
Device Catalogue Number436-2515X
Device Lot NumberCMDS0497
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/09/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/23/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/27/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/20/2020 Patient Sequence Number: 1
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