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 10/16/2023

Event Type  Injury  

Manufacturer Narrative

H3): the device was discarded, thus no investigation could be completed.H6): the device was not available for return, thus no conclusion could 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 Description

A lead extraction procedure commenced to remove three right ventricular (rv) leads and one right atrial (ra) lead due to cied system/pocket infection.Spectranetics lead locking devices (llds) were inserted into each lead to provide traction.A spectranetics glidelight laser sheath and a spectranetics tightrail rotating dilator sheath were used in the procedure.While a 13f tightrail (long) was used to remove one of the rv leads, it became stuck on the lead when attempting to remove the tightrail from the body.Although the tightrail was able to be removed out of the body, it could not be completely removed from the lead; therefore, the tightrail shaft was cut with heavy scissors.The rv lead was removed using a cook medical bulldog lead extender and another 13f tightrail.The other three leads were removed successfully with no reported patient harm.The patient survived the procedure.This report captures the 13f tightrail which became stuck on the rv lead, requiring intervention.

• 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: 18096312
• MDR Text Key: 327675064
• Report Number: 3007284006-2023-00060
• Device Sequence Number: 1
• Product Code: DRE
• UDI-Device Identifier: 00813132021658
• UDI-Public: (01)00813132021658(17)250808(10)FRJ23H08A
• 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: 11/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2023
• 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: FRJ23H08A
• 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: 08/08/2023
• 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: MEDTRONIC 5076 RA PACING LEAD; MEDTRONIC 5076 RV PACING LEAD; MEDTRONIC 5076 RV PACING LEAD; MEDTRONIC 6935 RV PACING LEAD; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS GLIDELIGHT LASER SHEATH; SPECTRANETICS LEAD LOCKING DEVICES
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American