MAUDE Adverse Event Report: SPECTRANETICS SPECTRANETICS TURBO ELITE ATHERECTOMY CATHETER

Model Number 420-006

Device Problem Hole In Material (1293)

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

Event Date 11/15/2017

Event Type  malfunction  

Manufacturer Narrative

No patient information is available.

Event Description

The representative was informed there was a hole in the inside of a spectranetics turbo elite catheter.No other detail available regarding the device; patient was discharged per operative plan with no reported patient injuries.This report is being filed due to potential for injury with recurrence based on reported complaint.

Manufacturer Narrative

Device returned for evaluation.Returned to manufacturer on 1/8/2018.Device evaluation completed 1/11/2018.When jacket was visually inspected, no defects seen or felt other than a small amount of wrinkling of the jacket.No hole was observed as previously reported.When device flushed with water, no leaks seen and water passes normally.When calibrating, laser light seen about 7 inches from tip coming through the jacket although the jacket is not breached.Under microscope dark mark seen under jacket at said spot leading to the conclusion that broken fibers are present at that spot; dark mark present as an effect of heat at spot.As a result of device evaluation, this is not a reportable event.No reported patient harm; no breach to device jacket; no potential for injury with recurrence based on device evaluation.

• 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: 7101168
• MDR Text Key: 95667236
• Report Number: 1721279-2017-00284
• 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: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/07/2019
• Device Model Number: 420-006
• Device Catalogue Number: 420-006
• Device Lot Number: FBA17H02A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2017
• 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): Other