MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number 417-156

Device Problems Material Puncture/Hole (1504); Material Deformation (2976)

Patient Problem Unintended Radiation Exposure (4565)

Event Date 08/31/2021

Event Type  malfunction  

Manufacturer Narrative

Patient date of birth, age at time of event unk.Patient gender unk.Patient's weight unk.Patient's ethnicity/race unk.Relevant tests/laboratory data unk.Other relevant history unk.The device was discarded, thus no investigation could be completed.Because the device was not returned for evaluation, the cause of the reported damage could not be determined.

Event Description

A peripheral atherectomy procedure commenced to treat a lesion, location unk.The physician chose to use a spectranetics turbo elite laser atherectomy catheter to treat the patient.During preparation for use, a hole in the laser sheath was observed.The device was not returned; however, photos of the device showed an area of the device's tail tube that appeared kinked and slightly twisted.A red dot was present in the photo in the area of the kink, which could indicate laser light emitting from the area; however this could not be confirmed.Another device was used to complete the procedure with no reported patient harm.Based on the photos provided, this event is being reported for unintended radiation exposure, potential for harm.

• Brand Name: SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: jill jacoby ; 9965 federal drive; colorado springs, CO 80921
• MDR Report Key: 12537440
• MDR Text Key: 273601964
• Report Number: 1721279-2021-00178
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00813132024741
• UDI-Public: (01)00813132024741(17)230624(10)FBG21F14A
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K170059
• 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: 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/24/2023
• Device Model Number: 417-156
• Device Catalogue Number: 417-156
• Device Lot Number: FBG21F14A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/31/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2021
• 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