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

Model Number	545-509
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient date of birth unavailable.Patient weight unavailable.Device evaluation: the device was returned and was evaluated on 16 oct 2019.Crepitation was present and the shaft held shape set while bending.The blades were retracted and in the proper position, concentric with the outer band.A small particle, which appeared to be metal, was detected on the device's distal band during this initial evaluation.Blood and biologics were found in both handle halves.The trigger pin was in the home track home position.Trigger particulate was found on the constant force spring.The front right trigger tab and front left trigger tab show signs of wear but the right has slightly more wear.The end cap and bushing removed easily, and the barrel/sleeve were removed with little force.Heavy biologics were found on the barrel.The sleeve will rotate around the barrel with force; however, attempts to manually rotate the inner shaft were unsuccessful.During decontamination of the device to prepare the device for x ray, the small particle that was detected on the distal band was no longer present; the particle could not be located/retrieved.It cannot be determined what the particle was made of, nor where it originated.The device was x rayed.There was nothing abnormal within the device, nor was there damage to the inner coils.
Event or Problem Description
During a lead extraction procedure, it was reported that while using a spectranetics tightrail device, the lead and the spectranetics lld being used could not be threaded through the tightrail device.The physician stated he felt an obstruction in the inner lumen of the tightrail device.It was also reported that when removing the tightrail, it felt tight within the inner lumen.A larger size device was used to complete the case, with no reported patient harm.During the device evaluation on 16 oct 2019, a small particle, appearing to be metal, was detected on the device's distal band.Since there would be the potential for serious injury (embolization) if this event were to recur, this report is being submitted.

• Brand Name: SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH
• Common Device Name: TIGHTRAIL
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 9313179
• Report Number: 1721279-2019-00193
• Device Sequence Number: 13986141
• Product Code: DRE
• UDI-Device Identifier: 00813132021634
• UDI-Public: (01)00813132021634(17)201008(10)FRH18K05A
• Combination Product (Y/N): Y
• Initial Reporter Country: EI
• PMA/510(K) Number: K150360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/22/2019
• 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: 10/08/2020
• Device Model Number: 545-509
• Device Catalogue Number: 545-509
• Device Lot Number: FRH18K05A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2019
• 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: 10/16/2019
• Initial Report FDA Received Date: 11/12/2019
• 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
• Patient Age: 60 YR
• Date Report Sent to FDA: 01/01/2005