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

Model Number 410-152

Device Problem Break (1069)

Patient Problem Unintended Radiation Exposure (4565)

Event Date 11/01/2022

Event Type  malfunction  

Manufacturer Narrative

Patient's date of birth, age: unk.Patient's 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.The cause of the reported failure could not be established.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.

Event Description

A peripheral atherectomy procedure commenced, indication for procedure/location unknown.The physician chose to use a spectranetics turbo elite laser atherectomy catheter to treat the patient.During preparation for use, a break in the catheter was observed.Another catheter was used to complete the procedure with no reported patient harm.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): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921
• MDR Report Key: 15839398
• MDR Text Key: 305178957
• Report Number: 1721279-2022-00209
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170059
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/21/2022

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: Health Professional
• Device Model Number: 410-152
• Device Catalogue Number: 410-152
• Device Lot Number: FBD22F27A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/02/2022
• Initial Date FDA Received: 11/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2022
• 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: GUIDE WIRE MANUFACTURER AND SIZE UNK; INTRODUCER SHEATH MANUFACTURER AND SIZE UNK; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM