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

Model Number	2200-2010
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient's dob and weight are unknown.This information was not available from the facility.Although the separated portion of the shaft occurred outside of the body, this is being reported as a conservative measure.Recurrence of the shaft separation could result in vessel obstruction, possible myocardial infarction, or may require surgical intervention.No patient injury.Patient information regarding relevant tests/laboratory data are unknown.This information was not available from the facility.The angiosculpt device was returned in two pieces.The shaft separated approximately 6" from the distal strain relief and the rx port was lacerated.Per the ifu, retained device component is listed as a possible adverse effect of the procedure.
Event or Problem Description
The angiosculpt device was used in a patient with severe coronary artery disease.During delivery to the heavily calcified lad lesion, resistance was noted.Upon removal, with the distal portion still in the patient, the shaft separated at the proximal end near the hub (outside of the body).No piece of the angiosculpt device was retained in the patient.The vessel was too calcified that no other treatment was available.The site does not perform atherectomy; therefore, the procedure was cancelled.

• 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: 8251190
• Report Number: 3005462046-2019-00001
• Device Sequence Number: 16542570
• Product Code: NWX
• UDI-Device Identifier: 00813132021146
• UDI-Public: 00813132021146
• Combination Product (Y/N): Y
• Initial Reporter State: CO
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/20/2018
• 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: 11/07/2019
• Device Model Number: 2200-2010
• Device Catalogue Number: 2200-2010
• Device Lot Number: G16110007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/31/2018
• 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: 12/20/2018
• Initial Report FDA Received Date: 01/15/2019
• 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