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

Model Number 2200-3510

Device Problems Difficult to Remove (1528); Mechanical Jam (2983)

Patient Problem No Information (3190)

Event Date 04/04/2016

Event Type  Injury  

Manufacturer Narrative

The patient's dob or age at time of event, gender, and weight are unknown.This information was not available from the facility.Adverse event was selected based on a conservative measure.The physician believed the patient was put at risk during the time the angiosculpt could not be removed from the patient which resulted in a prolonged procedure.Product problem was selected due to an overflow lifting of material at the distal bond observed during lab analysis.Recurrence of the malfunction could result in a mild vessel injury (non-flow limiting dissection).Patient information regarding relevant tests or laboratory data is unknown.This information was not available from the facility.(b)(4).The angiosculpt device was returned for evaluation.Visual inspection found an overflow lifting of material from the distal bond and the distal shaft was stretched and kinked.During retraction, the angiosculpt device got stuck inside the coronary artery.Excessive force was applied to remove from the patient, resulting in the damaged observed during lab analysis.

Event Description

During retraction, the angiosculpt balloon got stuck inside the coronary artery (lad).The guide catheter was advanced and excessive force was applied.After several attempts, the angiosculpt was able to be removed from the patient and finished the case with a nc balloon catheter.The patency of the artery was restored and the patient was discharged.

Manufacturer Narrative

The patient codes and device code were not included in the initial mdr.

• Brand Name: ANGIOSCULPT PTCA SCORING BALLOON CATHETER (RX)
• Type of Device: CATHETER, ANGIOPLASTY, CORONARY
• 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: 5613281
• MDR Text Key: 43846998
• Report Number: 3005462046-2016-00013
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P050018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/03/2018
• Device Model Number: 2200-3510
• Device Catalogue Number: 2200-3510
• Device Lot Number: G15120002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2015
• 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): Hospitalization