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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANGIOSCORE, INC. ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW) CATHETER, ANGIOPLASTY, PERIPHERAL

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ANGIOSCORE, INC. ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW) CATHETER, ANGIOPLASTY, PERIPHERAL Back to Search Results
Model Number 2249-50200
Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Patient Problems Atherosclerosis (1728); Peripheral Vascular Disease (2002)
Event Date 01/08/2015
Event Type  Injury  
Event Description

During retraction, the angiosculpt got stuck in the 6f ansel sheath. The physician pulled too hard and the device broke. The sheath was removed and all parts were retrieved with no complications. A new sheath was placed and procedure was completed by placing stents in the sfa which was according to plan.

 
Manufacturer Narrative

The patient information is unknown. The hospital declined to provide the information. During withdrawal, the angiosculpt device got stuck in the introducer sheath resulting in removal of the entire system. The physician placed a new sheath to complete the procedure with the planned stent placement, thus resulting in prolongation of the case. The angiosculpt device was not returned, thus no evaluation performed. It is possible that the excessive exertion of force applied by the user resulted in the device separation. Per the ifu, retained device component is listed as a possible adverse effect of the procedure.

 
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Brand NameANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW)
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL
Manufacturer (Section D)
ANGIOSCORE, INC.
5055 brandin court
fremont CA
Manufacturer Contact
robert greenleaf
5055 brandin court
fremont, CA 94538
7194472398
MDR Report Key4484740
MDR Text Key5501106
Report Number3005462046-2015-00002
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK133998
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 01/09/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/30/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/23/2016
Device MODEL Number2249-50200
Device Catalogue Number2249-50200
Device LOT NumberF14090021
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received01/09/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/10/2014
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: 01/30/2015 Patient Sequence Number: 1
Treatment
MEDICAL: 6F ANSEL SHEATH; MANUFACTURER AND SIZE UNKNOWN: GUIDE WIRE, COOK,
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