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U.S. Department of Health and Human Services

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

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THE SPECTRANETICS CORPORATION SPECTRANETICS TURBO-ELITE LASER ATHERECTOMY CATHETER TURBO ELITE Back to Search Results
Model Number 410-152
Device Problem Material Perforation (2205)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/03/2019
Event Type  malfunction  
Manufacturer Narrative
The user facility declined to provide patient information. The outside of the catheter was inspected and there was no exterior damage to the entire length of the catheter. Patency was check with an attempt to insert a guidewire through bifurcate and blockage was noticed under the strain relief of bifurcate cover. The bifurcate cover and outer jacket was removed to evaluate the fibers and inner lumen. Inner lumen looked to have a potential hole in the inner lumen under the strain relief where the blockage had originally been noticed. A breach to the inner lumen can provide potential for exposure to manufacturing materials not directly with tissue but fluids could allow talc to flow through body. Based on the investigations of the complaint the device has been marked reportable due to the potential for exposure to manufacturing materials.
 
Event Description
On (b)(6) 2019 a philips representative reported that during a peripheral atherectomy procedure for treatment of a plaque lesion in the mid superficial femoral artery (sfa), the 0. 9 over the wire (otw) turbo elite laser atherectomy catheter was found defective by the operator. The support wire wouldn't come out of the back end of the device. They opened another turbo elite laser atherectomy catheter and completed the case successfully. On (b)(6) 2019 the suspect device was evaluated. During evaluation it appeared that there was a hole in the inner-lumen of the device. Thus, this issue became a reportable event as a hole within the inner-lumen of the device could potentially expose the patient to manufacturing materials (talc) due to blood flowing through the inner-lumen during use.
 
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Brand NameSPECTRANETICS TURBO-ELITE LASER ATHERECTOMY CATHETER
Type of DeviceTURBO 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 Key8829113
MDR Text Key159695246
Report Number1721279-2019-00131
Device Sequence Number1
Product Code MCW
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K170059
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 01/01/2005,06/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/25/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/30/2020
Device Model Number410-152
Device Catalogue Number410-152
Device Lot NumberFBD18K24A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/08/2019
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 Received07/11/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/24/2018
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: 07/25/2019 Patient Sequence Number: 1
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