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

Model Number	545-509
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's date of birth, age: unk.Patient's weight: unk.Patient's ethnicity/race: unk.Relevant tests/laboratory data: unk.Other relevant history: unk.The device was not returned, thus no investigation could be completed and the complaint could not be confirmed.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.
Event or Problem Description
A lead extraction procedure commenced to remove a right atrial (ra) and a right ventricular (rv) lead in a right sided approach, due to occlusion and non function.Spectranetics lead locking devices (llds) were inserted into each lead to provide traction.A spectranetics tightrail sub-c rotating dilator sheath and fiab dilator sheaths were used in the procedure with no complications.The physician then chose a spectranetics 9f tightrail (long) to attempt removal of the ra lead.The tightrail was activated several times through the right subclavian vein and into the proximal superior vena cava (svc), where progress stalled.The tightrail stopped tracking down the ra lead, so the physician switched to attempt removal of the rv lead and removed the tightrail from the patient.Upon removal, it was noted a piece of metal was protruding from the tightrail's proximal end.The physician gently pulled this piece of metal, and pulled out what appeared to be the internal mechanism of the tightrail.The physician then used a spectranetics 14f glidelight laser sheath to attempt removal of the ra lead.The glidelight advanced down the subclavian and reached the proximal svc, where an obstruction was felt.The glidelight was removed from the patient's body and a huge tear was reported in the glidelight's outer sheath, near the proximal tip of the catheter (mdr #1721279-2022-00215).The procedure was completed with an 11f tightrail device and both leads were successfully removed with no reported patient harm.This report captures the 9f tightrail (long) with an exposed piece of metal, resulting in a sharp edge, potential for harm.
Additional Manufacturer Narrative
G3): the device evaluation and investigation were completed on 04jan2023.H3): a portion of the coil from the tightrail's inner lumen had broken, and was discovered protruding from the device's distal tip, exposing a sharp edge.The broken coil measured approximately 135 mm in length.No audible crepitation occurred along the length of the shaft and the shaft did not hold shape set.Biologics were observed at the tightrail's distal tip.The blades were extended (not retracted in their normal position), and appeared concentric with the outer band.With the handle halves separated, the internal housing was clean and free from biologics.The trigger pin was in the home track home position, but after removal of the right handle half, it sprung out of its location.The constant force spring was in good working condition, with minimal spool residue present.The trigger pin was in good working condition.All four trigger tabs showed minimal use.The end cap was returned pushed in and was removed with slight force, and the bushing and barrel/sleeve removed easily.The through hole of the barrel was clear; the barrel rotated easily within the sleeve, and the sleeve tabs were in proper position.The far track and home track corners were intact.Slight biologics were observed on the barrel and barrel tracks.The far track and home track return paths showed slight marring.The barrel/sleeve passed the drop test.The home track was slightly proud of the sleeve, and the far track barrel and sleeve were flush.Manual actuation was not attempted as the shaft appeared to be herniated.Further testing and x-ray concluded nothing was present within the shaft that would have caused the coil to break.The x-ray was unable to determine where the coil broke; the distal half of the broken coil was visible from the tightrail's distal tip, but the proximal portion was observed to be in proper position within the shaft.During cross section of the tightrail, it was confirmed that the portion of protruding coil came from the device's middle coil (the tightrail device has a tri-coil mechanism within its shaft), and was discovered stuck on the cam cutter head.The guide pin was functional, but guide pin material had pushed up onto itself at the pin's distal end, indicating heavy use.There was confirmed herniation of the tightrail's mid-shaft.H6): the cause of the broken coil and mid-shaft herniation could not be established.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.

• 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: 15898297
• Report Number: 1721279-2022-00216
• Device Sequence Number: 5103540
• Product Code: DRE
• UDI-Device Identifier: 00813132021634
• UDI-Public: (01)00813132021634(17)230818(10)FRH21H18A
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2023

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: 08/18/2023
• Device Model Number: 545-509
• Device Catalogue Number: 545-509
• Device Lot Number: FRH21H18A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 11/07/2022
• Supplement Date Received by Manufacturer: 11/07/2022
• Initial Report FDA Received Date: 12/01/2022
• Supplement Report FDA Received Date: 01/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2021
• 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: FIAB DILATOR SHEATHS; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LEAD LOCKING DEVICES; SPECTRANETICS TIGHTRAIL SUB-C DILATOR SHEATH; ST. JUDE MEDICAL 1888 RA PACING LEAD; ST. JUDE MEDICAL 1888 RV PACING LEAD
• Patient Sex: Male