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

Model Number 2001-3010

Device Problems Detachment Of Device Component (1104); Deflation Problem (1149)

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

Event Date 03/27/2018

Event Type  Injury  

Manufacturer Narrative

Correction to the rx ptca model number from 2200-3010 to rx ptca model number 2001-3010.

• Brand Name: ANGIOSCULPT PTCA SCORING BALLOON CATHETER (RX)
• Type of Device: CATHETER, PTCA, CUTTING/SCORING
• Manufacturer (Section D): SPECTRANETICS; 5055 brandin court; 94538; fremont CA
• Manufacturer (Section G): SPECTRANETICS; 5055 brandin court; fremont CA
• Manufacturer Contact: florie cazem ; 5055 brandin court; fremont, CA ; 510933-792
• MDR Report Key: 7437672
• MDR Text Key: 112895823
• Report Number: 3005462046-2018-00008
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): Y
• Reporter Country Code: GM
• PMA/PMN Number: P050018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,03/27/2018

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 Model Number: 2001-3010
• Device Catalogue Number: 2001-3010
• 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: Not provided
• Initial Date FDA Received: 04/17/2018
• Supplement Dates Manufacturer Received: 05/31/2018
• Supplement Dates FDA Received: 06/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR