MAUDE Adverse Event Report: SPECTRANETICS ANGIOSCULPT PTCA SCORING BALLOON CATHETER (RX); CATHETER, PTCA, CUTTING/SCORING

Model Number 2200-2510

Device Problem No Display/Image (1183)

Patient Problems Atherosclerosis (1728); Ischemic Heart Disease (2493)

Event Date 06/27/2018

Event Type  malfunction  

Manufacturer Narrative

The patient's dob, age at time of event, gender, and weight are unknown.This information was not available from the facility.The marker bands were not visible under fluoroscopy.Recurrence of the malfunction could result in over treatment/ geographic miss, possible vessel dissection, or possible surgical intervention.No patient injury reported.Patient information regarding relevant tests/laboratory data, or medical history is unknown.This information was not available from the facility.The angiosculpt device was discarded, thus the reported complaint could not be confirmed.

Event Description

Physician was unable to see the marker bands during use in patient.

• Brand Name: ANGIOSCULPT PTCA SCORING BALLOON CATHETER (RX)
• Type of Device: CATHETER, PTCA, CUTTING/SCORING
• Manufacturer (Section D): SPECTRANETICS; 5055 brandin court; fremont CA 94538
• Manufacturer (Section G): SPECTRANETICS; 5055 brandin court; fremont CA 94538
• Manufacturer Contact: florie cazem ; 5055 brandin court; fremont, CA 94538 ; 510933-792
• MDR Report Key: 7693764
• MDR Text Key: 114323045
• Report Number: 3005462046-2018-00017
• Device Sequence Number: 1
• Product Code: NWX
• UDI-Device Identifier: 00813132021177
• UDI-Public: 00813132021177
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P050018
• 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
• Report Date: 01/01/2005,06/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/06/2021
• Device Model Number: 2200-2510
• Device Catalogue Number: 2200-2510
• Device Lot Number: G18030008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 06/28/2018
• Initial Date FDA Received: 07/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2018
• 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