• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ANGIOSCORE, INC ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW) CATHETER, ANGIOPLASTY, PERIPHERAL Back to Search Results
Model Number 2092-6040
Device Problems Break (1069); Retraction Problem (1536)
Patient Problem No Information (3190)
Event Date 12/02/2015
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)(4). The angiosculpt was disposed, thus no evaluation performed.

 
Event Description

The angiosculpt device was used in the av fistula. After the first inflation at 10 atm, the balloon was deflated. During retraction, the angiosculpt got stuck inside the introducer sheath (terumo 7f). The physician removed the angiosculpt, introducer sheath, and guide wire as a unit. Upon removal, the scoring element was damaged but stayed 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.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key5294998
MDR Text Key33440209
Report Number3005462046-2015-00034
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeFR
PMA/PMN NumberK100303
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 12/02/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/14/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/09/2018
Device MODEL Number2092-6040
Device Catalogue Number2092-6040
Device LOT NumberG15090032
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 Received12/02/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/23/2015
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: 12/14/2015 Patient Sequence Number: 1
Treatment
MFG UNK: 0.014 GUIDE WIRE
-
-