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

Model Number	545-513
Medical Device Problem Codes	Failure to Align (2522); Material Deformation (2976); Mechanical Jam (2983); 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 3-4 inches of the tightrail sheath was flexible.Biologic material was visible on the outside of the device with a large amount observed at blades.The tri-coil was herniated within the device.The handle was in the full forward position with the blades extended.The handle was disassembled.Inside, the covers and trigger tabs were in excellent condition, showing little use.No biologic material was present inside of handle.The trigger pin was broken out of the trigger causing a rattling noise.Constant force spring showed little wear.Rear strain relief was in good condition.There was a groove cut into the barrel, with multiple areas of track damage from the trigger pin.This is evidence that the trigger pin jumped out of barrel channel and damaged the sleeve.The sleeve was deformed from the trigger pin.The far track corner was sheared off and lateral grooves were present on the outside of the sleeve.The sleeve tabs were in proper position, but the home track corner was broken.The drive unit would not actuate by hand as the tri-coil was herniated causing an abnormal noise.
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 14sep2018, that the inner coil was herniated.The herniation caused the blades to be 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 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: 7940901
• Report Number: 1721279-2018-00137
• Device Sequence Number: 16376488
• 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: 09/14/2018
• Initial Report FDA Received Date: 10/05/2018
• 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