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

Model Number 420-159

Device Problem Material Separation (1562)

Patient Problems Iatrogenic Source (2498); Device Embedded In Tissue or Plaque (3165)

Event Date 10/18/2018

Event Type  Injury  

Manufacturer Narrative

Patient information was requested from the site, but was not provided.The device was discarded by the site.Therefore, no evaluation will be performed.

Event Description

A philips representative reported that during a peripheral laser atherectomy procedure the radiopaque tip of the turbo-elite laser atherectomy catheter 420-159 separated from the device.The physician reported it was left in the profunda of the superficial femoral artery.

• Brand Name: SPECTRANETICS TURBO-ELITE LASER ATHERECTOMY CATHETER
• Type of Device: TURBO ELITE
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: catherine eaton ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 8062306
• MDR Text Key: 126897506
• Report Number: 1721279-2018-00162
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K180694
• 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: 01/01/2005,10/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/10/2020
• Device Model Number: 420-159
• Device Catalogue Number: 420-159
• Device Lot Number: FBH18H06A
• Was Device Available for Evaluation?: No
• 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: 10/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2018
• 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): Other