MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION TIGHTRAIL ROTATING DILATOR SHEATH

Model Number	545-513
Medical Device Problem Codes	Failure to Align (2522); Deformation Due to Compressive Stress (2889); Noise, Audible (3273); Physical Resistance/Sticking (4012); Sharp Edges (4013)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was requested from the site, but not provided.During evaluation of the device it was found that the first two inches of the tightrail sheath were filled with dried biological material.At the 3 inch mark, internal coils appeared to be herniated and a coil was extending from the tip.Also, the blades were stuck in the extended position.The handle was disassembled and biologic material was noted on the internal handle.Mechanical trigger, pin, and key post were in good shape.The trigger spring and tabs had minimal wear.The strain relief was adhered with blood.The tri-coil was completely herniated.When the handle was actuated the blades would not rotate.The home track corner was destroyed.The barrel has wear from the sleeve.Heavy wear noted on barrel track, possibly from actuation after herniation.Barrel does not pass smoothly through sleeve, likely caused by damage to the barrel from the pin.Device shows signs of heavy use.
Event or Problem Description
A philips representative reported that during a cardiac lead management procedure on (b)(6) 2018, the handle of the tightrail 545-513 device malfunctioned.The blades were not rotating, and the handle made a clicking noise.No patient harm occurred.It was reported that this was a right sided entry into the body, with extreme calcium lesions.The suspect tightrail 545-513 device was returned for evaluation and it was found during evaluation on (b)(6) 2018, that the inner coil was herniated.The herniation caused pieces of the coil to extend out of the tip of the device.Also, the blades were stuck in the extended position.These evaluation findings made the manufacturer aware that this issue could lead to patient injury if it were to recur, as the blades and coil extending through the tip of the device could lead to unintended tissue damage and/or emboli.

• Brand Name: TIGHTRAIL ROTATING DILATOR SHEATH
• Common Device Name: TIGHTRAIL
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 7932408
• Report Number: 1721279-2018-00135
• Device Sequence Number: 16574672
• Product Code: DRE
• UDI-Device Identifier: 00813132020897
• UDI-Public: 00813132020897
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K150360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/10/2018
• Report Date (Section F): 01/01/2005

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/01/2019
• Device Model Number: 545-513
• Device Catalogue Number: 545-513
• Device Lot Number: FRJ17L30A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2018
• Initial Report FDA Received Date: 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 01/01/2005