MAUDE Adverse Event Report: SPECTRANETICS CORPORATION SPECTRANETICS TURBO-POWER LASER ATHERECTOMY CATHETER

Model Number 423-050

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/06/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Vascular intervention case using a turbo-power directional laser sheath.The physician was using a 7fr ansel sheath and a 0.014 spartacore wire.The physician completed 2 passes using the laser sheath when it was noted that laser light was coming out of the catheter sheath.The laser sheath was then removed and the patient's treatment was completed using another device without adverse event.The damaged area of the catheter never entered the patient.This event is being reported due to the potential for exposure to manufacturing materials and inadvertent exposure to laser energy.

Manufacturer Narrative

Device evaluation; there is no indication of a manufacturing or design failure in this event.There was no injury to the patient as a result of this event.The case was completed with a dcb.

• Brand Name: SPECTRANETICS TURBO-POWER LASER ATHERECTOMY CATHETER
• Type of Device: TURBO-POWER
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 9965 federal dr; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS
• Manufacturer Contact: sondra chandler ; 9965 federal dr; colorado springs, CO 80921 ; 719447-253
• MDR Report Key: 5602245
• MDR Text Key: 44372008
• Report Number: 1721279-2016-00054
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: KK152181
• 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,Followup,Followup
• Report Date: 04/06/2016

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: Physician
• Device Expiration Date: 01/20/2018
• Device Model Number: 423-050
• Device Catalogue Number: 423-050
• Device Lot Number: FMP16A18A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/06/2016
• Initial Date FDA Received: 04/22/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/25/2016; 03/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2014
• 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
• Patient Age: 71 YR
• Patient Weight: 109