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

Model Number	545-513
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Perforation of Vessels (2135); Great Vessel Perforation (2152)
Date of Event	04/22/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
Patient's date of birth unk.Patient's weight unk.Device lot number, expiration date unk.The device was discarded, thus no investigation could be completed.Device manufacture date unk because lot number unk.
Event or Problem Description
A lead extraction procedure commenced to remove a right atrial (ra), a right ventricular (rv) and a left ventricular (lv) lead due to cied system/pocket infection.The lv lead was removed with gentle traction alone.Spectranetics lead locking devices (llds) were inserted into the ra and rv leads to provide traction; cook medical bulldog lead extenders were also attached to both leads, providing additional traction.Attempting to remove the ra lead, the physician used a spectranetics 13f tightrail rotating dilator sheath and its outer sheath.The device advanced to the beginning of where the first dual coil was present on the rv lead; however it was difficult to advance further as there was lead on lead binding and adherence to the vessel wall.Eventually, the ra lead became free, but this took effort using the tightrail's outer sheath.Attempted removal of the rv lead using the tightrail was next, again encountering stalled progress after reaching the beginning of the first dual coil.The outer sheath could not advance past half the length of the first dual coil, so the physician switched to a spectranetics 16f glidelight laser sheath with its outer sheath.The outer sheath would not advance past this point either, and the belief was that the outer sheath was snowplowing (bunching up the rv lead's insulation) and it would require a larger outer sheath to advance.The physician attempted a cook medical 13f sheath, but this sheath would not advance past the same point.The physician used a new 13f tightrail (the previous tightrail's outer sheath tip had bent with use earlier in the case).The physician was able to advance over the snowplowed area and when he was almost at the lead's tip, the lead released.There was no drop in the patient's blood pressure; however, after approximately 2 minutes the patient's condition began to deteriorate.Cpr was initiated and the surgical team was called.Further rescue efforts, including bypass and sternotomy were performed.An innominate/superior vena cava (svc) perforation was discovered, extending from the innominate vein to the bottom of the svc.A patch repair of the perforation was performed.Unfortunately, the patient did not survive.This report captures the 13f tightrail, the last device in use when the innominate/svc perforation occurred, requiring intervention but resulting in death.There was no alleged malfunction of any spectranetics devices in use during the procedure.

• 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: 14342524
• Report Number: 1721279-2022-00087
• Device Sequence Number: 5221184
• Product Code: DRE
• UDI-Device Identifier: 00813132020897
• UDI-Public: 00813132020897
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K150360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/22/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: 545-513
• Device Catalogue Number: 545-513
• 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: 04/22/2022
• Initial Report FDA Received Date: 05/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: COOK MEDICAL BULLDOG LEAD EXTENDERS; LV LEAD MANUFACTURER AND MODEL UNK; RA PACING LEAD MANUFACTURER AND MODEL UNK; RV ICD LEAD MANUFACTURER AND MODEL UNK; SECOND SPECTRANETICS 13F TIGHTRAIL DILATOR SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LEAD LOCKING DEVICES
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White