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

Model Number 2200-2510

Device Problems Entrapment of Device (1212); Retraction Problem (1536); Unraveled Material (1664)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/20/2019

Event Type  Injury  

Manufacturer Narrative

The patient'' dob, age at time of event, gender, or weight are unknown.This information was not available from the facility.The angiosculpt device was caught on the guide wire and removed as a system.Rewiring of the lesion was required to complete the procedure, resulting in prolongation of the case.No patient injury reported.Patient information regarding relevant tests/ laboratory data or medical history are unknown.This information was not available from the facility.The lot number was not provided, thus the following information are unknown: expiration date and manufacture date.The angiosculpt device was returned intact to a 0.014" guide wire.Visual examination found a damaged and accordion-like balloon and the scoring element was elevated.In addition, the transition tubing, shaft, and core wire were all damaged.During functional testing, the guide wire was unable to be removed from the angiosculpt device.Per the ifu, if unusual resistance is met during manipulation, carefully remove the entire catheter system.

Event Description

The angiosculpt device was used to treat a moderately calcified rca with slight vessel tortuosity.During insertion, the scoring element got caught on the guide wire and the scoring element started to unravel within the coronary artery.The device could only be removed as a whole system, thus rewiring of the lesion was required to complete the procedure with other interventional balloons and stent.No patient injury reported.

• 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: ana tan ; 5055 brandin court; fremont, CA 94538 ; 510933-798
• MDR Report Key: 9613436
• MDR Text Key: 185505824
• Report Number: 3005462046-2020-00001
• 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: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2200-2510
• Device Catalogue Number: 2200-2510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2020
• 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
• Date Manufacturer Received: 12/23/2019
• 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
• Patient Outcome(s): Hospitalization; Required Intervention