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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 2249-60200
Device Problem Entrapment of Device (1212)
Patient Problems Atherosclerosis (1728); Peripheral Vascular Disease (2002)
Event Date 01/14/2015
Event Type  Malfunction  
Event Description

When the physician removed the angiosculpt device, it was hung up on a very tight area of the sfa. Upon removal, it looked like the tip of the balloon malformed.

 
Manufacturer Narrative

The angiosculpt device was returned for eval. Visual examination found a section of the scoring element detached at the distal ring and damaged the distal bond. The transition tubing was stretched, necked, and damaged. The shaft was kinked in multiple areas. According to the info rec'd from the hosp, it is probably that the severely calcified lesion caused or contributed to the detachment of the scoring element ring. Per the ifu, a vessel dissection or a retained device component are possible adverse effects 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 Key4491408
MDR Text Key16851172
Report Number3005462046-2015-00003
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 01/14/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/03/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/24/2016
Device MODEL Number2249-60200
Device Catalogue Number2249-60200
Device LOT NumberF14060037
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer01/21/2015
Is The Reporter A Health Professional? Yes
Date Manufacturer Received01/21/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/10/2014
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: 02/03/2015 Patient Sequence Number: 1
Treatment
0.014" GUIDE WIRE, MFR UNK; 6F INTRODUCER SHEATH, MFR UNK; 6F GUIDE CATHETER, MFR UNK
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