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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANGIOSCORE, INC. ANGIOSCULPT PTCA SCORING BALLOON CATHETER (RX); CATHETER, ANGIOPLASTY, CORONARY

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ANGIOSCORE, INC. ANGIOSCULPT PTCA SCORING BALLOON CATHETER (RX); CATHETER, ANGIOPLASTY, CORONARY Back to Search Results
Model Number 2200-30158
Device Problems Detachment Of Device Component (1104); Use of Device Problem (1670)
Patient Problems Atherosclerosis (1728); Ischemic Heart Disease (2493)
Event Date 09/22/2014
Event Type  malfunction  
Event Description
The angiosculpt scoring element came off into the sheath.Additional info received on 10/09/2014: the nitinol cage pulled from the balloon o the way out of the tuohy-borst.The physician stated that they did not deflate the balloon all the way.
 
Manufacturer Narrative
The pt info is unk.The hospital was not able to provide the info.The angiosculpt device was returned for lab analysis.Visual examination confirmed the scoring element was stuck inside the 3-way tuohy-borst.The scoring element separated from the damaged distal bond and the damaged intermediate bond.Two scoring element strut rings broke at the distal section.The transition tubing was stretched and the rx port was lacerated.The user did not follow the ifu.Also, retained device component is listed as a possible adverse effect of the procedure.
 
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Brand Name
ANGIOSCULPT PTCA SCORING BALLOON CATHETER (RX)
Type of Device
CATHETER, ANGIOPLASTY, CORONARY
Manufacturer (Section D)
ANGIOSCORE, INC.
fremont CA
Manufacturer Contact
kent jones
5055 brandin court
fremont, CA 94538
5109337904
MDR Report Key4177000
MDR Text Key5155153
Report Number3005462046-2014-00034
Device Sequence Number1
Product Code NWX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P050018
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 09/23/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/16/2017
Device Model Number2200-30158
Device Catalogue Number2200-3015
Device Lot NumberF14060025
Other Device ID NumberM3702200301511
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer10/01/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/23/2014
Initial Date FDA Received10/14/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/02/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
INTRODUCER SHEATH; GUIDE CATHETER; GUIDE WIRE; MFRS AND SIZES UNK:
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