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U.S. Department of Health and Human Services

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

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ANGIOSCORE, INC. ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW) LIT: CATHETER, ANGIOPLASTY, PERIPHERAL Back to Search Results
Model Number 2332-8040
Device Problems Balloon (419); Inflation Problem (1310); Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)
Patient Problems Tissue Damage (2104); Therapeutic Response, Decreased (2271); Test Result (2695)
Event Date 12/01/2015
Event Type  Injury  
Manufacturer Narrative

The physician inflated the balloon to 17 atm (above rbp of 12 atm) and burst radially. A skin infusion at the puncture site was performed in order to remove the angiosculpt and introducer sheath. Patient information regarding relevant tests or laboratory data is unknown. This information was not available from the facility. The angiosculpt device was returned intact to the introducer sheath. Visual examination confirmed a radial balloon burst but remained intact to the device. In addition, a kink at the distal end of the strain relief was observed. During functional testing, the angiosculpt could not be removed from the introducer sheath. The angiosculpt device was used off-label. The ifu states the balloon pressure should not exceed the rbp (12 atm).

 
Event Description

The angiosculpt was used in the arteriovenous fistula (avf) at cephalic vein in the upper left arm. The angiosculpt was inflated to 12 atm for 3 minutes but the angiographic result was not satisfactory. The angiosculpt was inflated for the second time at 12 atm for 3 minutes but the angiographic result was not satisfactory. During the third inflation at 17 atm (above the rated burst pressure (rbp) of 12 atm) for 3 minutes, the balloon ruptured radially. It was not possible to retrieve the angiosculpt through the introducer sheath (terumo: 6f, 11cm), thus a slight skin incision at the puncture site was performed in order to remove the balloon and introducer sheath.

 
Manufacturer Narrative

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

 
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Brand NameANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW)
Type of DeviceLIT: CATHETER, ANGIOPLASTY, PERIPHERAL
Manufacturer (Section D)
ANGIOSCORE, INC.
fremont CA
Manufacturer Contact
5055 brandin court
fremont, CA 94538
5109337926
MDR Report Key5331903
MDR Text Key34734644
Report Number3005462046-2015-00036
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeFR
PMA/PMN NumberK150634
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 12/01/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/23/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/06/2016
Device MODEL Number2332-8040
Device Catalogue Number2332-8040
Device LOT NumberG15070001
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer12/09/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/01/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/20/2015
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: 12/23/2015 Patient Sequence Number: 1
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