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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 2076-5040
Device Problem Material Frayed (1262)
Patient Problems Atherosclerosis (1728); Peripheral Vascular Disease (2002)
Event Date 11/26/2014
Event Type  Malfunction  
Event Description

After balloon inflation, the angiosculpt device was removed from the pt. Upon removal, the user found a problem with the distal bond. No pt injury occurred but the user requested an investigation of the distal bond region.

 
Manufacturer Narrative

The pt info is unknown. The hospital declined to provide the info. The angiosculpt device was returned for eval. Visual examination found a distal bond peel but remained intact to the device. The balloon is inverted at the distal end and the transition tubing is twisted. 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.
fremont CA
Manufacturer Contact
robert greenleaf
5055 brandin court
fremont, CA 94538
7194472398
MDR Report Key4437694
MDR Text Key5317612
Report Number3005462046-2015-00001
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK100303
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Distributor
Reporter Occupation
Type of Report Initial
Report Date 11/27/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/15/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/03/2017
Device MODEL Number2076-5040
Device Catalogue Number2076-5040
Device LOT NumberF14020039
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer12/26/2014
Is The Reporter A Health Professional? Yes
Date Manufacturer Received12/26/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/18/2014
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: 01/15/2015 Patient Sequence Number: 1
Treatment
GUIDE CATHETER; INTRODUCER SHEATH; MFR AND SIZES ARE UNK: GUIDE WIRE
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