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 2-3 inches of the tightrail sheath was filled with dried biological material.The tri-coil was herniated, with pieces of the coil hanging from the tip.The trigger portion of the handle was stuck in the middle position with the blades not quite exposed.The handle was disassembled.Minimal wear was observed on the interior of the handle halves and trigger tabs.Very clean inside.Trigger pin is seated correctly in home position and in good condition.Trigger spring has no wear.The home track barrel corner is in good condition.There was excessive damage on the barrel from the pin cutting a new path due to heavy pulling forces.Sleeve tabs are in proper position.The far track corner is intact.The track has signs of the pin rubbing on it hard, creating a ridge.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 13sep2018, that the inner coil was herniated.The herniation caused pieces of the coil to extend out of the tip of the device.These evaluation findings made the manufacturer aware that this issue could lead to patient injury if it were to recur, as the 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: 7933959
• Report Number: 1721279-2018-00136
• Device Sequence Number: 19203624
• 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: 10/04/2018
• 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