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

Model Number	545-511
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A2): patient''s date of birth unk a4): patient''s weight unk b7): other relevant history unk h3): the device has been returned to the manufacturer.The device evaluation and investigation are currently ongoing.H6): a conclusion for the reported event is not yet available.A supplemental mdr will be submitted upon the completion of the device evaluation and investigation.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 ventricular (rv) lead due to noise on the lead/suspected fracture.A spectranetics lead locking device (lld) was inserted into the lead, with suture being used as well, to provide traction.Beginning with a spectranetics glidelight laser sheath, followed by an 11f tightrail rotating dilator sheath, a ''crunching'' sound was noted after several trigger actuations, and the tightrail stopped advancing.Upon removing the tightrail from the patient, it became stuck on the lead approximately 1-2 inches outside the body, and could not be removed.Therefore, the lead was cut, which removed the proximal portion of the lead with the tightrail intact.To remove the lead remnant, a cook medical bulldog lead extender and new suture were used as the traction platform, and a new 11f tightrail was used to successfully extract the rv lead with no reported patient harm.This report captures the 11f tightrail which became stuck on the rv lead, requiring intervention.
Additional Manufacturer Narrative
G3): the device evaluation and investigation were completed on 30nov2023.H3): the tightrail device was returned to the manufacturer, along with a portion of a lead and an lld.The tightrail shaft was cut approximately 24 inches from the proximal end.Visual inspection found heavy biologics noted in the distal tip, as well as around the lead and lld.The lead was present within the tightrail's shaft, extending 2 7/8 inches beyond the distal end, with suture and biologics wrapped around the lead.Additionally, the lld was observed inside the tightrail's shaft at the distal end, and the lld braid had been cut.The length of the tightrail shaft held a shape set, and slight audible crepitation could be heard along the length.During functional testing, the end cap was removed with slight force, and biologics were present on the hypotube.The drive shaft could be partially actuated, and the shaft did not appear to be herniated.Using a borescope, biologics were noted throughout the shaft.There was no design, process or use related failure identified.H6): based on the device evaluation and investigation, it has been determined that the failure was likely due to the excessive biologic buildup in addition to the lead and suture present within the shaft.Investigation findings code 180 added (code 3233 no longer applicable).Investigation conclusions codes 50 and 4310 added (code 11 no longer applicable).All other codes remain applicable as listed in the initial mdr.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: TIGHTRAIL ROTATING DILATOR SHEATH
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-2465
• MDR Report Key: 18145316
• Report Number: 3007284006-2023-00071
• Device Sequence Number: 7609655
• Product Code: DRE
• UDI-Device Identifier: 00813132021641
• UDI-Public: (01)00813132021641(17)250725(10)FRK23G25A
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/25/2025
• Device Model Number: 545-511
• Device Catalogue Number: 545-511
• Device Lot Number: FRK23G25A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/15/2023
• Supplement Report FDA Received Date: 12/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2023
• 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 5024 RV PACING LEAD; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS GLIDELIGHT LASER SHEATH; SPECTRANETICS LEAD LOCKING DEVICE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White