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

Model Number 417-152

Device Problem Crack (1135)

Patient Problems Unintended Radiation Exposure (4565); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/14/2021

Event Type  malfunction  

Manufacturer Narrative

Patient information unavailable. (b)(4). The manufacturer is anticipating the return of the device for evaluation, but has not received it at this time.

Event Description

A peripheral atherectomy procedure commenced to provide treatment to the patient's superficial femoral artery(sfa). The physician chose to use a spectranetics turbo elite laser atherectomy catheter to treat the patient. During use within the patient, red light was seen emitting from the side of the catheter. It was reported there was a crack in the catheter; however, the physician was unsure of the efficacy of the device. The turbo elite device was reportedly used to complete the procedure with no reported patient harm. This event is being reported due to the potential for exposure to manufacturing materials as well as inadvertent exposure to laser energy/radiation. The manufacturer is anticipating return of the turbo elite catheter for evaluation, but has not received it at this time.

• 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 Contact: 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 11807090
• MDR Text Key: 265172097
• Report Number: 1721279-2021-00086
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K170059
• Number of Events Reported: 123
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative,distri

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 417-152
• Device Catalogue Number: 417-152
• Device Lot Number: FAZ21A20A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 06/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 05/11/2021 Patient Sequence Number: 1