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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 2237-40100
Device Problems Sticking (1597); Device Dislodged or Dislocated (2923)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/27/2015
Event Type  Injury  
Manufacturer Narrative

The angiosculpt got stuck in the introducer sheath. The physician removed the angiosculpt, introducer sheath, and guide wire as a unit. A new catheter, introducer sheath, and guide wire were used to complete the procedure, thus resulting in prolongation of the case. (b)(6). The angiosculpt was disposed, thus no evaluation performed.

 
Event Description

The angiosculpt device was planned to be used in a long high calcified lesion in a small femoral artery stenosis but got stuck inside the introducer sheath (boston scientific 7f, 45cm). The angiosculpt, introducer sheath, and guide wire were removed as a unit. The physician had to pull strongly on the angiosculpt, and as a result the scoring element was completely dislocated but remained intact to the device. A new catheter, introducer sheath, and guide wire were used to complete the procedure.

 
Manufacturer Narrative

The patient codes and device codes were not included in the initial mdr.

 
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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 94538
Manufacturer (Section G)
ANGIOSCORE, INC
Manufacturer Contact
florie cazem
5055 brandin court
fremont, CA 94538
510933-792
MDR Report Key5291360
MDR Text Key33348068
Report Number3005462046-2015-00033
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeFR
PMA/PMN NumberK112182
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/27/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/11/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/21/2017
Device MODEL Number2237-40100
Device Catalogue Number2237-40100
Device LOT NumberF14080027
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/27/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/08/2014
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: 12/11/2015 Patient Sequence Number: 1
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