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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	03/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's weight unavailable.Device lot number, expiration date unavailable.Device manufacture date unavailable because lot number unavailable.(b)(4).
Event or Problem Description
A lead extraction procedure commenced to remove a right ventricular (rv), a right atrial (ra) and a left ventricular (lv) lead due to a redundant lead.It was noted that the implant duration of the ra and rv leads was 280 months.Spectranetics lead extraction tools were used in this procedure; however when the physician was using a spectranetics 13f tightrail sub-c rotating dilator sheath within the subclavian region, and when the ra and rv leads were freed simultaneously from a point within the subclavian as well, the patient's blood pressure dropped.It was also reported at this time that the lv lead also became caught in the subclavian area, but was successfully removed with traction.Reportedly, the patient's blood pressure drop was not accompanied by an apparent injury for approximately 45 minutes, and the patient was responding to other treatment.However, evidence of an injury was seen on fluoroscopy approximately 45 minutes after the initial blood pressure drop.Rescue efforts began, including bypass and sternotomy.A left subclavian tear was discovered and was successfully repaired.It is unknown whether the tear occurred with use of the tightrail sub-c device, or from the leads as they came free together and were pulled out through the subclavian.This report is being submitted to capture the tightrail sub-c device which was in use within the patient in the area of injury when the patient's blood pressure dropped.There is no alleged malfunction of any spectranetics devices in use during the procedure.
Additional Manufacturer Narrative
H3): the device was discarded, thus no investigation could be completed.H6): added codes: 4755, 4619, and 4621.

• 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
• MDR Report Key: 11706683
• Report Number: 1721279-2021-00071
• Device Sequence Number: 3895043
• Product Code: DRE
• UDI-Device Identifier: 00813132022808
• UDI-Public: 00813132022808
• Combination Product (Y/N): Y
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K161333
• Number of Events Summarized: 123
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 560-013
• Device Catalogue Number: 560-013
• Device Lot Number: UNAVAILABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/25/2021
• Supplement Date Received by Manufacturer: 06/06/2021
• Initial Report FDA Received Date: 04/22/2021
• Supplement Report FDA Received Date: 06/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BOSTON SCIENTIFIC 438-10 RA PACING LEAD; BOSTON SCIENTIFIC 438-10 RV PACING LEAD; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS GLIDELIGHT LASER SHEATH; SPECTRANETICS LEAD LOCKING DEVICES; SPECTRANETICS VISISHEATH DILATOR SHEATH; ST. JUDE MEDICAL 1458Q LV LEAD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 33 YR