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	10/14/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
A lead extraction procedure commenced to remove a right atrial (ra) and a right ventricular (rv) lead due to lead fracture.A spectranetics lead locking device (lld) was inserted into the rv lead, making it down to the beginning of the distal coil of the rv lead.A cook medical bulldog lead extender was also used on the rv lead.The physician chose a spectranetics tightrail 11f sub-c rotating dilator sheath to attempt removal of the rv lead.During attempted extraction, the cook bulldog device cut the high voltage cables of the lead, but the extraction continued.After the tightrail sub-c device progressed, the physician needed to switch to a longer device.While he was attempting to take the tightrail sub-c device off the lead, the lead became stuck inside the tightrail sub-c device.To remove the device from the rv lead, the physician cut the back end of the lld which freed the tightrail sub-c device.A cook medical lead extender was then added to the lld and a spectranetics 14f glidelight laser sheath was loaded onto the cut lld and cook medical lead extender to again attempt removal of the rv lead.The rv and ra leads were bound together, so the physician switched attempts to remove the ra lead with use of the 14f glidelight device and an lld to provide traction.The ra lead was successfully removed.The physician then attempted removal of the rv lead again, using the 14f glidelight and a spectranetics visisheath dilator sheath, but the lead cables kept being pushed distally.The physician chose to upsize to a 16f glidelight device with a large visisheath.The rv lead was eventually removed using traction.The procedure was successfully completed with no reported patient harm.This report captures the tightrail sub-c device which became stuck on the rv lead, requiring intervention.
Additional Manufacturer Narrative
Patient's weight unk.The device has not been returned to the manufacturer, thus no investigation could be 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): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921
• MDR Report Key: 12791039
• Report Number: 1721279-2021-00218
• Device Sequence Number: 12007654
• Product Code: DRE
• UDI-Device Identifier: 00813132022792
• UDI-Public: (01)00813132022792(17)230310(10)FRP21C10A
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Report Date (Section B): 10/14/2021

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: 03/10/2023
• Device Model Number: 560-011
• Device Catalogue Number: 560-011
• Device Lot Number: FRP21C10A
• Was Device Available for Evaluation?: No
• 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: 10/14/2021
• Initial Report FDA Received Date: 11/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2021
• 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: BIOTRONIK PROTOGO S65 RV ICD LEAD; BIOTRONIK S63 RA PACING LEAD; COOK MEDICAL BULLDOG LEAD EXTENDER; COOK MEDICAL LEAD EXTENDER; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LEAD LOCKING DEVICES; SPECTRANETICS VISISHEATH DILATOR SHEATH
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American