MAUDE Adverse Event Report: SPECTRANETICS SPECTRANETICS TURBO ELITE ATHERECTOMY CATHETER

Model Number 410-152

Device Problems Hole In Material (1293); Defective Device (2588)

Patient Problems No Known Impact Or Consequence To Patient (2692); Radiation Exposure, Unintended (3164)

Event Date 05/03/2017

Event Type  malfunction  

Manufacturer Narrative

No patient information available from facility.Relevant tests/laboratory data, other relevant history unavailable from facility.Although this device was not used in a patient procedure, this event is being reported as a malfunction due to a device likely to cause or contribute to a death or serious injury if it were to recur.

Event Description

During preparation for us in a vascular intervention procedure, a turbo elite device was removed from its packaging.However, the physician noticed a hole in the device, at the tip of the catheter, where the fiber is located.The physician determined the catheter was defective and another device was opened and used in the procedure.Patient was discharged per operative plan.Unfortunately the device was not returned for evaluation.

Manufacturer Narrative

Device 510k number has been corrected to reflect the most current and up to date number, as of the date of the initial report.

Manufacturer Narrative

Potential for exposure to manufacturing materials and potential for aro exposure explained in this section (was not explained in the initial mdr submission), due to the reported hole in the device.(b)(4).

Event Description

In the initial fda mdr submitted 23 may 2017, the physician noticed a hole in the device, at the tip of the catheter.The device was not returned to the manufacturer for evaluation.Due to the report of a hole in the device, there is the potential for exposure to manufacturing materials and exposure to accidental radiation.Although the initial mdr was submitted, this information was not clarified in the initial report.

• Brand Name: SPECTRANETICS TURBO ELITE ATHERECTOMY CATHETER
• Type of Device: TURBO ELITE
• Manufacturer (Section D): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 6585312
• MDR Text Key: 75926798
• Report Number: 1721279-2017-00101
• Device Sequence Number: 1
• Product Code: MCW
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,05/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/20/2019
• Device Model Number: 410-152
• Device Catalogue Number: 410-152
• Device Lot Number: FBD17D14A
• 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: 07/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2017
• 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): Required Intervention