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

Model Number	2200-2510
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Atherosclerosis (1728); Peripheral Vascular Disease (2002)
Date of Event	06/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient's dob, age at time of event, or weight is unknown.This information was not available from the facility.The angiosculpt device separated while inserting through the introducer sheath.Recurrence of the malfunction could require surgical intervention for device removal.Although the separation occurred outside of the body, this is being reported as a conservative measure.No patient injury.Patient information regarding relevant tests or laboratory data is unknown.This information was not available from the facility.The angiosculpt device was returned in two pieces.The device separated at the proximal shaft near the hub.The angiosculpt ptca device was used off-label in the periphery.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 to treat a severely calcified peroneal artery.When the device was advanced over the.014 wire and through the 6f sheath, the proximal hypotube broke about 10-12 cm from the proximal hub.The location of the break occurred outside of the body, before entry into the sheath.The proximal and distal piece of the device were both retracted back over the wire and a replacement device was used successfully without incident.

• 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: 7681890
• Report Number: 3005462046-2018-00016
• Device Sequence Number: 19181976
• Product Code: NWX
• UDI-Device Identifier: 00813132021177
• UDI-Public: 00813132021177
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• 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): 06/26/2018
• 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: No Information
• Device Expiration Date: 03/03/2020
• Device Model Number: 2200-2510
• Device Catalogue Number: 2200-2510
• Device Lot Number: G17030004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2018
• 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: 06/26/2018
• Initial Report FDA Received Date: 07/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AHASHI: 0.014" CONFIANZA PRO GUIDE WIRE; TERUMO: 6F PINNACLE DESTINATION SHEATH
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 01/01/2005