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

Model Number 2155-2540

Device Problem Peeled/Delaminated (1454)

Patient Problem No Patient Involvement (2645)

Event Date 12/07/2015

Event Type  Malfunction  

Manufacturer Narrative

The angiosculpt device was not used in the patient. Lab analysis confirmed a distal bond peel. Recurrence of the malfunction could result in a mild vessel injury (non-flow limiting dissection). (b)(4). The angiosculpt device was returned for evaluation. Visual examination confirmed a distal bond peel but remained intact to the device. Two scoring element struts appeared bent and elevated at the distal end. Per the ifu, retained device component is listed as a possible adverse effect of the procedure.

Event Description

During preparation for use, it was noticed that the scoring element was not tightly wrapped around the distal end of the balloon. The angiosculpt was returned for evaluation. Visual examination confirmed a distal bond peel.

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: 5336364
• MDR Text Key: 35205430
• Report Number: 3005462046-2015-00037
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (Y/N): N
• Reporter Country Code: US
• PMA/PMN Number: K101735
• 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: 12/07/2015

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 12/30/2015
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device EXPIRATION Date: 10/19/2018
• Device MODEL Number: 2155-2540
• Device Catalogue Number: 2155-2540
• Device LOT Number: G15100031
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 12/15/2015
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/16/2015
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 11/04/2015
• 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: 12/30/2015 Patient Sequence Number: 1