MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number	545-511
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A lead extraction procedure commenced, extraction and lead location unk.The physician used a spectranetics tightrail rotating dilator sheath to aid in lead extraction.Per report, after approximately 10 actuations of the tightrail trigger, the blades would no longer rotate.The procedure was completed using another tightrail with no reported patient harm.However; during device evaluation on (b)(6) 2022, it was discovered that the blades of the tightrail were not retracted and were found to be in an extended position, past the outer band of the device.This report captures the tightrail which was found with extended blades during device evaluation, potential for harm.
Additional Manufacturer Narrative
Patient''s date of birth, age unk.Patient''s gender unk.Patient''s weight unk.Patient''s ethnicity/race unk.Relevant tests/laboratory data unk.Other relevant history unk.The device was returned and evaluated by a cross functional team.The device had audible crepitation the entire length of the shaft and it held shape set (meaning significant biologics were present within tightrails shaft).The blades were in an extended position (should be retracted), past the outer band at the tightrails distal tip.It could not be determined if the blades were concentric with the outer band due to excessive biologics.With the handle halves separated, the inside of the device was clean of biologics.The trigger tabs on the handle showed heavy wear and the trigger pin was sheared off and found loose inside the handle.Based on the orientation of the barrel and sleeve, it appears the barrel rotation stopped mid track, likely the reason for the blades being extended.The home track corner on the barrel was rounded.The sleeve appeared damaged as if the trigger pin came in contact with the edge of the sleeve.Additionally, a bronze streak from the trigger pin was observed on the surface of the sleeve, extending from the damaged edge to the surface of the sleeve.During manual actuation, the shaft did not actuate as intended, due to biologics.H6): based on the device damage found during device evaluation and investigation, this failure likely occurred due to resistance encountered at the distal tip from heavy calcification or the other biologics.Although excessive biologics caused trigger pin and sleeve damage and the device''s blades to be extended, this has been determined to be a design related failure due to the damage observed.

• Brand Name: SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921
• MDR Report Key: 14596275
• Report Number: 1721279-2022-00104
• Device Sequence Number: 2097725
• Product Code: DRE
• UDI-Device Identifier: 00813132021641
• UDI-Public: (01)00813132021641(17)231202(10)FRK21M01A
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K150360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/03/2022

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: 12/02/2023
• Device Model Number: 545-511
• Device Catalogue Number: 545-511
• Device Lot Number: FRK21M01A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2022
• Initial Report FDA Received Date: 06/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH; TRACTION PLATFORM MANUFACTURER UNK
• Patient Sex: Unknown