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U.S. Department of Health and Human Services

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

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THE SPECTRANETICS CORPORATION SPECTRANETICS TURBO-POWER LASER ATHERECTOMY CATHETER Back to Search Results
Model Number 423-050
Device Problems Material Perforation (2205); Material Deformation (2976)
Patient Problems Iatrogenic Source (2498); Radiation Exposure, Unintended (3164)
Event Date 12/18/2018
Event Type  malfunction  
Manufacturer Narrative
The site did not wish to provide patient information. It was reported that the turbo power device was curved on about half of the catheter, appearing as if it had memory to the shape of the package. Upon attempt to load catheter onto wire, the turbo power would not easily advance and had a lot of drag. The device reportedly never entered the patient's body. The case was completed with use of another turbo power with no reported patient harm. The device was returned and evaluated. Upon visual inspection, outer jacket had a noticeable bend 41 cm from distal tip and was leaking fluid. 12cm proximal of the scuff mark: jacket felt "crusty" when flexed. Device was fully patent when passing a 0. 018 guide wire through the lumen. The bent area and scuff mark were evaluated; outer jacket coating was noticed around fibers. Water was added and fibers became slick - confirming that coating was present inside the jacket and on the fibers. Production process issue confirmed; outer jacket damage. Outer jacket coating entered into the catheter through scuff in the outer jacket. This event is being reported due to the potential for exposure to manufacturing materials as well as inadvertent exposure to laser energy/radiation.
 
Event Description
On 18dec2018: a philips representative reported that during a peripheral atherectomy procedure to treat an 80 percent stenosed diffusely diseased superficial femoral artery (sfa). It was decided to treat the lesion with a spectranetics 2. 3 turbo-power laser atherectomy catheter 423-050. It was noted upon removing the turbo power from the packaging that it had a curve on about half of the catheter. It appeared the shape was set as the device had been in the package. They flushed and attempted to load the catheter on the guidewire. Upon loading the turbo power onto a. 018 sv5 wire, the turbo-power device would not easily advance forward and had a lot of drag. The device never entered the guide sheath or the patient's body. A new turbo power was opened and the patient was successfully treated without incident. On 07feb2019: during evaluation of the suspect turbo-power device, it was detected under microscopic evaluation, that the turbo-power had a breach in the outer jacket. This event is being reported due to the potential for exposure to manufacturing materials as well as inadvertent exposure to laser energy/radiation.
 
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Brand NameSPECTRANETICS TURBO-POWER LASER ATHERECTOMY CATHETER
Type of DeviceTURBO-POWER
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 Key8376255
MDR Text Key141079558
Report Number1721279-2019-00026
Device Sequence Number1
Product Code MCW
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K180694
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 01/01/2005,12/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/27/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/05/2020
Device Model Number423-050
Device Catalogue Number423-050
Device Lot NumberFMP18F25A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/01/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Event Location No Information
Date Report to Manufacturer01/10/2005
Date Manufacturer Received02/07/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/25/2018
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: 02/27/2019 Patient Sequence Number: 1
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