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

Model Number 2334-8040

Device Problems Device Operates Differently Than Expected (2913); Difficult to Open or Close (2921)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/03/2016

Event Type  malfunction  

Manufacturer Narrative

Lab analysis confirmed an overflow lifting of material at the distal bond but remained intact to the device.Recurrence of the malfunction could result in a mild vessel injury (non-flow limiting dissection).No pre-op labs or testing performed.Patient's medical history or co-morbidities is unknown.This information was not available from the facility.Udi# (b)(4).The angiosculpt was returned intact to the introducer sheath.Visual examination found air present inside the distal portion of the balloon with the proximal portion of the balloon lodged inside the introducer sheath.One scoring element strut was lifted at the distal end with two scoring element struts bent and overlapped.The distal bond was damaged with material overflow lifting from the bond and the transition tubing was necked and severely stretched.During functional testing, the device was unable to be removed from the introducer sheath; therefore, the device was pulled distally to expose the proximal portion of the balloon with no issues noted.An indeflator was used to remove as much air as possible and even after manual manipulation to bring the balloon profile down, the device was still unable to be removed from the introducer sheath.Based on the lab analysis, it is probable the user applied some degree of force resulting in the damaged distal bond.Per the ifu, retained device component is listed as a possible adverse effect of the procedure.

Event Description

The angiosculpt device could not be removed from the introducer sheath (6f cook) after use.The angiosculpt device, 0.014" guide wire, and introducer sheath were removed as a unit.Procedure was completed.Note: lab analysis confirmed an overflow lifting of material at the distal bond.

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: 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: 5472087
• MDR Text Key: 39682336
• Report Number: 3005462046-2016-00008
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150634
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/18/2016
• Device Model Number: 2334-8040
• Device Catalogue Number: 2334-8040
• Device Lot Number: G15090044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/02/2015
• 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): Other
• Patient Age: 56 YR
• Patient Weight: 73