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

Model Number 2200-2510

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Atherosclerosis (1728); Peripheral Vascular Disease (2002)

Event Date 06/26/2018

Event Type  malfunction  

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 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)
• Type of Device: CATHETER, PTCA, CUTTING/SCORING
• Manufacturer (Section D): SPECTRANETICS; 5055 brandin court; fremont CA 94538
• Manufacturer (Section G): SPECTRANETICS; 5055 brandin court; fremont CA 94538
• Manufacturer Contact: florie cazem ; 5055 brandin court; fremont, CA 94538 ; 510933-792
• MDR Report Key: 7681890
• MDR Text Key: 113790455
• Report Number: 3005462046-2018-00016
• Device Sequence Number: 1
• Product Code: NWX
• UDI-Device Identifier: 00813132021177
• UDI-Public: 00813132021177
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P050018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/01/2005,06/26/2018

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
• Device Operator: 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
• 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: 06/26/2018
• Initial Date FDA Received: 07/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: AHASHI: 0.014" CONFIANZA PRO GUIDE WIRE; TERUMO: 6F PINNACLE DESTINATION SHEATH
• Patient Outcome(s): Other