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

Model Number	2200-2015
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient's age at time of event or dob, gender, and weight are unknown.The facility declined to provide this information.The angiosculpt device was unable to deliver to the lesion due to the tortuous anatomy.The physician had to do a guide wire exchange three times in order to complete the procedure with a new balloon device, resulting in prolongation of the case.Patient information regarding relevant tests/laboratory data or medical history is unknown.This information was not available from the facility.The angiosculpt device was returned for investigation.Visual examination found a shaft tear and a lacerated rx port.The tear was located at the intermediate shaft, proximal to the rx port.A section of the core wire protruded from the shaft tear, but remained intact to the device.Based on the complaint details and the returned product investigation, the damaged shaft was likely caused by the improper handling of the device and morphology.
Event or Problem Description
The angiosculpt device was used together with a asahi, prowater 0.014" guide wire and a medtronic, ebu 6f guide catheter.The angiosculpt was attempted to be delivered to the tortuous anatomy by pushing and twisting, but unable to deliver.The guide wire was removed and switched to different wire (brand unknown), but still unable to deliver, thus the guide wire and device were removed as a unit.Upon removal, the balloon shaft was unraveled.No complications to the patient was reported.

• Brand Name: ANGIOSCULPT PTCA SCORING BALLOON CATHETER (RX)
• Common Device Name: CATHETER, PTCA, CUTTING/SCORING
• Manufacturer (Section D): SPECTRANETICS; 5055 brandin ct; fremont CA 94538
• MDR Report Key: 7962298
• Report Number: 3005462046-2018-00022
• Device Sequence Number: 19253002
• Product Code: NWX
• UDI-Device Identifier: 00813132021153
• UDI-Public: 00813132021153
• Combination Product (Y/N): Y
• 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): 09/06/2018
• 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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/10/2021
• Device Model Number: 2200-2015
• Device Catalogue Number: 2200-2015
• Device Lot Number: G18040012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2018
• 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: 09/24/2018
• Initial Report FDA Received Date: 10/12/2018
• 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: Hospitalization
• Date Report Sent to FDA: 01/01/2005