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

Model Number 545-513

Device Problem Entrapment of Device (1212)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/19/2024

Event Type  Injury  

Event Description

A lead extraction procedure commenced to remove a right atrial (ra), two right ventricular (rv models 430-07 and 430-01), and a left ventricular (lv) leads due to iced system/pocket infection.Spectranetics lead locking devices (llds) were inserted into each lead to provide traction.Multiple spectranetics devices (16f glidelight laser sheath, 13f tightrail rotating dilator sheath/tightrail outer sheath, and visisheath dilator sheath) were used during the procedure.Beginning by successfully extracting the ra and the lv leads, efforts were then focused on the two remaining rv leads.Extraction attempts alternated back and forth several times between the leads.While using the 13f tightrail/outer sheath on the rv lead (model 430-07), advancement was made down to the rv, when progress stalled.While attempting to withdraw the tightrail from the patient, it became stuck on the lead and would not pull back.Using twisting motions, trigger pulls, and pulling both the tightrail and outer sheath back, the device was withdrawn just to the lead vessel entry point.Tissue was removed from the distal end, but the device still would not pull back.Using a long introducer sheath on both ends, the device would still not dislodge.There was not enough lead exposed in order to cut the lead and maintain control for extraction; therefore, the shaft was cut with wire cutters to preserve the lead''s length.The tightrail was then freed and removed.Arthrex fiberwire suture for traction was used to prep the lead again, and with use of a 16f glidelight and visisheath, the lead was successfully extracted.The remaining rv lead (model 430-01) was removed with no issues.The procedure was completed with no reported patient harm.This report captures the 13f tightrail which became stuck on the lead, requiring intervention.

Manufacturer Narrative

A2): patient's date of birth unk.A4): patient's weight unk.B6): relevant tests/laboratory data unk.B7): other relevant history unk.H3/h6): the device was discarded, thus no investigation could be completed and the cause of the reported complaint 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: TIGHTRAIL ROTATING DILATOR SHEATH
• Type of Device: 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 ; 719447-246
• MDR Report Key: 18716977
• MDR Text Key: 335527358
• Report Number: 3007284006-2024-00034
• Device Sequence Number: 1
• Product Code: DRE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 545-513
• Device Catalogue Number: 545-513
• Device Lot Number: FRJ23L22A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BOSTON SCIENTIFIC 430-07 RV ICD LEAD; MEDTRONIC 430-01 RV ICD LEAD; MEDTRONIC 4398 LV LEAD; MEDTRONIC 5594 RA PACING LEAD; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LEAD LOCKING DEVICES; SPECTRANETICS VISISHEATH DILATOR SHEATH
• Patient Outcome(s): Required Intervention
• Patient Age: 90 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White