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

Model Number 2332-8040

Device Problems 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.

• Brand Name: ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW)
• Type of Device: LIT: CATHETER, ANGIOPLASTY, PERIPHERAL
• Manufacturer (Section D): ANGIOSCORE, INC.; fremont CA
• Manufacturer Contact: 5055 brandin court; fremont, CA 94538 ; 5109337926
• MDR Report Key: 5331903
• MDR Text Key: 34734644
• Report Number: 3005462046-2015-00036
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00813132022204
• UDI-Public: 01008131320222041716070610G15070001
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K150634
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• 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 Received: 12/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/06/2016
• Device Model Number: 2332-8040
• Device Catalogue Number: 2332-8040
• Device Lot Number: G15070001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/09/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention