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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 DILATATION CATHETER

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CLEARSTREAM TECHNOLOGIES LTD. SAVVY LONG OTW PTA CATHETER PTA DILATATION CATHETER Back to Search Results
Catalog Number UNKNOWN SAVVY LONG
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Perforation of Vessels (2135)
Event Date 11/06/2015
Event Type  Injury  
Manufacturer Narrative

As the lot number for the device was not provided, a manufacturing review could not 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. 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 in an article in the diagn interv radiol (dir) interventional radiology titled, "clinical outcome of angiosome-oriented infrapoplitieal percutaneous transluminal angioplasty for isolated infrapopliteal lesions in the patients with critical limb ischemia" that two patients had an arterial perforation with severe bleeding after infrapopliteal percutaneous transluminal angioplasty (ip-pta) for lesion of the arterior tibial artery (ata), treated with prolonged balloon tamponade, and coil embolization and additional recanalization on the non-target artery.

 
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Brand NameSAVVY LONG OTW PTA CATHETER
Type of DevicePTA DILATATION CATHETER
Manufacturer (Section D)
CLEARSTREAM TECHNOLOGIES LTD.
moyne upper
enniscorthy, co. wexford
EI
Manufacturer (Section G)
CLEARSTREAM TECHNOLOGIES LTD.
moyne upper
enniscorthy, co. wexford
EI
Manufacturer Contact
judith ludwig
1625 w 3rd st.
tempe, AZ 85281
4803032689
MDR Report Key8648383
MDR Text Key146334206
Report Number9616666-2019-00064
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeKS
PMA/PMN NumberK072947
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN,LITERATUR
Reporter Occupation
Type of Report Initial
Report Date 05/28/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/28/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNKNOWN SAVVY LONG
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/02/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 05/28/2019 Patient Sequence Number: 1
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