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

Model Number	560-011
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A lead extraction procedure commenced to remove a right atrial (ra) and a right ventricular (rv) lead due to bacteremia.The physician chose a spectranetics tightrail sub-c rotating dilator sheath to aid in lead removal.During the procedure, the tightrail device stopped working.There was a difference in the sound it made as the physician squeezed the handle, as if it had broken inside and was no longer turning, which was confirmed under fluoroscopy.After use, it was observed the device''s shaft was very loose and flimsy.A new device was opened and the procedure was completed with no reported patient harm.The tightrail device was received in two pieces on (b)(6) 2022.The handle and the shaft were separate, which would prevent the blades (located at the distal tip of the device''s shaft) from actuating, since actuation of the blades originates in the device''s handle.During device evaluation on (b)(6) 2022, it was discovered that the blades of the tightrail device were not retracted and were in an extended position, past the outer band of the device.This report captures the tightrail device returned with the separated shaft and extended blades, potential for harm.
Additional Manufacturer Narrative
The device was evaluated by a cross functional team.The handle and shaft were returned in two pieces, with the inner and outer coils broken under the strain relief.Severe biologics were seen throughout the device.Observing the distal tip of the shaft, the blades were found to be in an extended position.With the handle halves separated, the device showed heavy to normal use.Due to the significant amount of biologics seen on the inside of the device, the barrel was unable to rotate within the sleeve.After the device was soaked and ultrasonically cleaned, the barrel revealed severe marring on the barrel on the home track return path and slight marring on the far track return path.This marring caused the barrel and sleeve to fail the drop test.Manual actuation could not be tested due to the shaft being broken into two pieces.Additional analysis showed evidence of a uniform directional ductal tensile break, indicative of stress being placed on the device.There was no evidence of a design, production or use related failure.It was concluded that the broken shaft was caused by exceeding the design limits of the tensile strength of the device during use.However, it could not be determined how or when the limits of the tensile strength were exceeded.

• 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: 14758298
• Report Number: 1721279-2022-00117
• Device Sequence Number: 1348414
• Product Code: DRE
• UDI-Device Identifier: 00813132022792
• UDI-Public: (01)00813132022792(17)230901(10)FRP21J01A
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K161333
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/21/2022

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: 09/01/2023
• Device Model Number: 560-011
• Device Catalogue Number: 560-011
• Device Lot Number: FRP21J01A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2022
• 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: 05/24/2022
• Initial Report FDA Received Date: 06/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2021
• 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: MEDTRONIC 5086 RA PACING LEAD; MEDTRONIC 5086 RV PACING LEAD; TRACTION PLATFORM, MANUFACTURER UNK
• Patient Age: 52 YR
• Patient Sex: Male