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

Model Number	2200-2510
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Codes	Atherosclerosis (1728); Ischemic Heart Disease (2493)
Date of Event	06/27/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Physician was unable to see the marker bands during use in patient.

• Brand Name: ANGIOSCULPT PTCA SCORING BALLOON CATHETER (RX)
• Common Device Name: CATHETER, PTCA, CUTTING/SCORING
• Manufacturer (Section D): SPECTRANETICS; 5055 brandin court; fremont CA 94538
• MDR Report Key: 7693764
• Report Number: 3005462046-2018-00017
• Device Sequence Number: 16532709
• Product Code: NWX
• UDI-Device Identifier: 00813132021177
• UDI-Public: 00813132021177
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P050018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/28/2018
• Report Date (Section F): 01/01/2005

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
• Operator of Device: 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
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2018
• Initial Report FDA Received Date: 07/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 01/01/2005