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

Model Number	560-013
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient weight unk.Patient's ethnicity/race unk.Relevant tests/laboratory data unk.Other relevant history unk.The device was returned to the manufacturer on 08 mar 2022.The device has been returned to the manufacturer.The device evaluation and investigation have begun, but have not been completed.A supplemental mdr will be submitted when the device evaluation and investigation are complete.
Event or Problem Description
A lead extraction procedure commenced to remove a right atrial (ra) and a right ventricular (rv) lead due to cied system/pocket infection.Spectranetics lead locking devices (llds) were inserted into each lead to provide traction.The physician attempted extraction of both leads, using a spectranetics 16f glidelight laser sheath.The physician then switched to a spectranetics 13f tightrail sub-c rotating dilator sheath on the two leads.While working to remove the ra lead, the tightrail sub-c device became stuck on the lead, requiring additional intervention to remove the device from the lead, but was successful (mdr #1721279-2022-00048).The 16f glidelight device was used again, and the ra lead was successfully extracted.Attempting removal of the rv lead, the physician used the 16f glidelight device, then switched to a spectranetics tightrail (long) device.This device became stuck on the rv lead, at the area of the lead's superior vena cava (svc) coil, requiring intervention to remove the device from the rv lead, but was successful (mdr #1721279-2022-00049).Once out of the body, there was dense, calcific tissue visible at the distal tip of the tightrail (long) device.After this, the physician alternated devices in order to extract the rv lead, using the 16f glidelight device and then a new tightrail (long) device was opened and used to successfully extract the rv lead.The procedure was completed, with no reported patient harm.This report captures the tightrail sub-c device present on the ra lead when it became stuck on the lead, requiring intervention for lead removal.
Additional Manufacturer Narrative
G3: the device evaluation and investigation were completed on 16 mar 2022.H3: device evaluation: the device was returned and evaluated by a cross functional team.Biologics were seen in the distal tip of the device.Blades were retracted, in the proper position, and concentric with the outer band.With the handle halves separated, biologics were seen on the inside of each handle, and the trigger tabs showed normal to heavy wear.Looking at the barrel and sleeve, severe biologics were seen throughout.The home track corner was sheared off and the sleeve does not pass drop test due to the biologics.During manual actuation, the blades extend and retract as intended.Other than biologics, no other foreign material was seen in the devices shaft.After soaking, biologics were still seen in the distal tip of the device and the barrel sleeve passed the drop test after biologics were cleaned off.This failure is due to biological build-up causing the lead to become stuck within the shaft of the device.H6: investigation findings and conclusions codes populated after device evaluation and investigation completed.

• 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: 13737433
• Report Number: 1721279-2022-00048
• Device Sequence Number: 4685250
• Product Code: DRE
• UDI-Device Identifier: 00813132022808
• UDI-Public: (01)00813132022808(17)231129(10)FRQ21L29A
• Combination Product (Y/N): N
• Initial Reporter State: DC
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2022

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: 11/29/2023
• Device Model Number: 560-013
• Device Catalogue Number: 560-013
• Device Lot Number: FRQ21L29A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2022
• 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: 02/15/2022
• Supplement Date Received by Manufacturer: 03/16/2022
• Initial Report FDA Received Date: 03/11/2022
• Supplement Report FDA Received Date: 03/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2021
• 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: MEDTRONIC 5076 RA PACING LEAD; MEDTRONIC 6947 RV ICD LEAD; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LEAD LOCKING DEVICES; SPECTRANETICS TIGHTRAIL (LONG) DILATOR SHEATHS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female