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

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.

• Brand Name: ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW)
• Type of Device: CATHETER, 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 Key: 5294998
• MDR Text Key: 33440209
• Report Number: 3005462046-2015-00034
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K100303
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• 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 Received: 12/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/09/2018
• Device Model Number: 2092-6040
• Device Catalogue Number: 2092-6040
• Device Lot Number: G15090032
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2015
• 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
• Treatment: MFG UNK: 0.014 GUIDE WIRE
• Patient Outcome(s): Hospitalization
• Patient Weight: 90