MAUDE Adverse Event Report: ANGIOSCORE, INC. ANGIOSCORE PTCA SCORING BALLOON CATHETER (RX); CATHETER, ANGIOPLASTY, CORONARY

Model Number 2200-2506

Device Problem Material Separation (1562)

Patient Problem Calcium Deposits/Calcification (1758)

Event Date 02/03/2015

Event Type  Injury  

Event Description

After multiple devices and balloons failed to expand the lesion, an angiosculpt device was forcefully advanced sequentially and inflated approximately 15 times in an (b)(6) severely tortuous and calcified lad.After the final inflation, retrieval attempts led to the deflated balloon being punctured and snared on a proximal calcified area of the lesion.Numerous attempts to dislodge the angiosculpt device resulted in separation from its shaft.The stable patient was sent for surgical removal of snared distal end of angiosculpt.Additional information received on 02/09/2015: surgery went well, the angiosculpt device was removed from the patient.

Manufacturer Narrative

The patient's weight is unknown.This information was not available from the hospital.The angiosculpt device is with the hospital's risk management, thus no evaluation performed.Based on the information received, it is probable that the severely tortuous and calcified lesion caused or contributed to the device separation.Per the ifu, retained device component is listed as a possible adverse effect of the procedure.Placeholder.

• Brand Name: ANGIOSCORE PTCA SCORING BALLOON CATHETER (RX)
• Type of Device: CATHETER, ANGIOPLASTY, CORONARY
• Manufacturer (Section D): ANGIOSCORE, INC.; 5055 brandin court; fremont CA
• Manufacturer (Section G): ANGIOSCORE, INC.
• Manufacturer Contact: florie cazem ; 5055 brandin court; fremont, CA 94538 ; 510933-792
• MDR Report Key: 4542536
• MDR Text Key: 5359817
• Report Number: 3005462046-2015-00005
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/25/2017
• Device Model Number: 2200-2506
• Device Catalogue Number: 2200-2506
• Device Lot Number: F14080034
• Other Device ID Number: M3702200250615
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/03/2015
• Initial Date FDA Received: 02/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MAN. UNK 7F GUIDE CATHETER; MAN. UNK 7F INTRODUCER SHEATH; MAN. UNK 0.014" GUIDE WIRE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 80 YR