MAUDE Adverse Event Report: SPECTRANETICS ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW); CATHETER, PERCUTANEOUS, CUTTING/SCORING

Model Number	2290-50100
Medical Device Problem Codes	Detachment Of Device Component (1104); Retraction Problem (1536)
Health Effect - Clinical Codes	Atherosclerosis (1728); Peripheral Vascular Disease (2002)
Date of Event	04/02/2018
Type of Reportable Event	Serious Injury

• Brand Name: ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW)
• Common Device Name: CATHETER, PERCUTANEOUS, CUTTING/SCORING
• Manufacturer (Section D): SPECTRANETICS; 5055 brandin court; fremont CA 94538
• MDR Report Key: 7449160
• Report Number: 3005462046-2018-00009
• Device Sequence Number: 109518
• Product Code: PNO
• UDI-Device Identifier: 00813132021597
• UDI-Public: 00813132021597
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K112182
• 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): 04/02/2018
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 02/01/2020
• Device Model Number: 2290-50100
• Device Catalogue Number: 2290-50100
• Device Lot Number: G17020001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2018
• 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: Not provided
• Initial Report FDA Received Date: 04/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 0
• Concomitant Medical Products and Therapy/Usage Dates: ABBOTT: 0.14" SUPRA CORE GUIDE WIRE; TERUMO: 6F INTRODUCER SHEATH
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Date Report Sent to FDA: 01/01/2005