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

Model Number	560-011
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient''s date of birth unk.Patient''s weight unk.Other relevant history unk.Device lot number, expiration date unk.Device evaluation: the device was evaluated on 01 dec 2021 by a cross functional team.The lld was seen exiting out of the proximal end of the tightrail sub-c device.Using pliers, the team attempted to pull the lld out of the tightrail device''s distal end without success.Pulling the lld from the proximal end, the lld was able to be extracted.Knotted suture, lead jacket and lead insulation were removed from the tightrail device''s shaft.With the lld, lead fragments and knotted suture removed, the tightrail sub-c device actuated and performed as intended.It has been determined that the lld, knotted suture, lead jacket and lead insulation exceeded the tightrail sub-c shaft''s inner diameter, causing the objects to become stuck within the tightrail sub-c device.There were no manufacturing or design concerns identified for this device.Device manufacture date unk because lot number unk.
Event or Problem Description
A lead extraction procedure commenced to remove a right atrial (ra), two right ventricular (rv) (pacing and icd types) and two left ventricular (lv) leads due to cied system/pocket infection.During the procedure, the physician was using a spectranetics 11f tightrail sub-c rotating dilator sheath to attempt to remove the rv icd lead.As the physician was taking out the tightrail device to exchange for another tool, the rv icd lead became wedged inside the tightrail device.This occurred after the tightrail device was outside the patient''s body, with the device being stuck on the proximal end of the rv icd lead.After trying to rotate the tightrail device by turning the entire handle while holding onto the lead, it would not move.The physician cut the lead where it came out of the tip of the tightrail device.This event did not cause patient harm.All leads were removed successfully and the patient survived the procedure.This report captures the 11f tightrail sub-c device present on the rv icd lead when it became stuck on the lead, requiring intervention for lead removal.

• 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): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921
• MDR Report Key: 12957353
• Report Number: 1721279-2021-00233
• Device Sequence Number: 5423975
• Product Code: DRE
• UDI-Device Identifier: 00813132022792
• UDI-Public: 00813132022792
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K161333
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/12/2021

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 Model Number: 560-011
• Device Catalogue Number: 560-011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2021
• 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: 11/12/2021
• Initial Report FDA Received Date: 12/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: ABBOTT 1156T LV LEAD; MEDTRONIC 4193 LV LEAD; MEDTRONIC 5594 RA PACING LEAD; MEDTRONIC 6949 RV ICD LEAD; SPECTRANETICS 12F GLIDELIGHT LASER SHEATHS; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS VISISHEATH DILATOR SHEATH; ST. JUDE MEDICAL LDA210Q RV PACING LEAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White