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	11/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's weight unk.Patient's ethnicity/race unk.Other relevant history unk.The device was not returned, thus no investigation could be completed.
Event or Problem Description
A lead extraction procedure commenced to remove a right atrial (ra) and a right ventricular (rv) lead due to bacteremia and removal of an abandoned pacemaker system.Spectranetics lead locking devices (llds) were inserted into each lead to provide traction.The physician attempted removal of the ra lead by using a spectranetics 11f tightrail sub-c rotating dilator sheath.Upon attempting removal of the lead from the device, the tightrail became stuck.It was noted that there was a piece of calcium stuck at the tip of the tightrail.The ra lead was cut and the tightrail was removed.The physician was unable to unlock the lld from the ra lead since it had been cut, and both the ra lead with the lld inside were cut and capped and remained in the patient (mdr #1721279-2021-00246).The physician then attempted to unlock the lld from the rv lead but was unsuccessful, so the rv lead with the lld inside were cut and capped and remained in the patient (mdr #1721279-2021-00247).There was 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
D9): the device was returned to the manufacturer on 04 jan 2022.G3): the device evaluation and investigation were completed on 19 jan 2022.H3): device evaluation: the device was returned and evaluated by a cross functional team.Heavy crepitation was felt the entire length of the shaft.Heavy biologics and the lead''s outer jacket (insulation) were seen in the device''s distal tip.With the handle halves separated, biologics were present and the internal mechanisms were in good working condition.Looking at the barrel, the far track corner was slightly broken and the home track corner had collapsed.The home track return path and far track return path had significant marring.Due to this marring the barrel sleeve did not pass drop test; therefore the drive shaft was unable to be manually actuated.The device was then soaked and ultrasonically cleaned.Afterwards, the device was able to be manually actuated and calcium and a partially broken lead jacket was pulled out of the distal tip of the device.The broken lead jacket and the calcium were found to be adhered together.It was determined the tightrail device became stuck and unable to actuate due to the excessive biologics and calcifications that were adhered to the lead.

• 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: 13014616
• Report Number: 1721279-2021-00245
• Device Sequence Number: 19264064
• Product Code: DRE
• UDI-Device Identifier: 00813132022792
• UDI-Public: (01)00813132022792(17)23001(10)FRP21D01A
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,Followup
• Report Date (Section B): 11/29/2021

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 Expiration Date: 04/01/2023
• Device Model Number: 560-011
• Device Catalogue Number: 560-011
• Device Lot Number: FRP21D01A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2022
• 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: 11/29/2021
• Supplement Date Received by Manufacturer: 01/19/2022
• Initial Report FDA Received Date: 12/15/2021
• Supplement Report FDA Received Date: 02/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2021
• 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 4058M RA PACING LEAD; MEDTRONIC 5024M RV PACING LEAD; MEDTRONIC 5076 RA PACING LEAD; MEDTRONIC 5076 RV PACING LEAD; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS GLIDELIGHT LASER SHEATH; SPECTRANETICS LEAD LOCKING DEVICES; SPECTRANETICS VISISHEATH DILATOR SHEATH
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male