MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH

Model Number	545-513
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Great Vessel Perforation (2152); Iatrogenic Source (2498)
Date of Event	03/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's date of birth unavailable.Patient's sex unavailable.Patient's weight unavailable.Device lot number, expiration date unavailable.Device manufacture date unavailable because lot number unavailable.Additional patient, device and procedure detail has been requested but is unavailable.
Event or Problem Description
Summary of the translation from spanish to english: a lead extraction procedure commenced to remove a right ventricular (rv) lead, indication for removal unknown.Also unknown was if there were any additional leads targeted for removal.The lead was prepped using a spectranetics lead locking device (lld) to act as a traction platform.The physician chose to use a spectranetics 13f tightrail rotating dilator sheath to attempt extraction of the rv lead.Progress was made through the subclavian region, and when reaching the lead's proximal coil at the height of the superior vena cava (svc), they experienced difficulty with adhesions.At this time, the patient's blood pressure suddenly dropped.Rescue efforts began immediately, including use of a rescue device.Cardiac arrest occurred; chest compressions began.The time of cardiac arrest was approximately 10 minutes.A sternotomy was performed and an extensive svc perforation was discovered.External perfusion was applied, along with administering red blood cells, plasma and fluids to the patient.The svc perforation was successfully repaired, and the patient was stabilized after four hours of surgery.There was question regarding the neurological impact to the patient because of 10 minutes in cardiac arrest; however, the physician reported the patient is well, woke up, with no brain damage.There was no alleged malfunction of any spectranetics device used in the procedure.

• Brand Name: SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH
• Common Device Name: TIGHTRAIL
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 9946534
• Report Number: 1721279-2020-00094
• Device Sequence Number: 19393309
• Product Code: DRE
• UDI-Device Identifier: 00813132020897
• UDI-Public: 00813132020897
• Combination Product (Y/N): Y
• Initial Reporter Country: SP
• PMA/510(K) Number: K150360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/24/2020
• Report Date (Section F): 01/01/2005

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
• Device Lot Number: UNAVAILABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2020
• Initial Report FDA Received Date: 04/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 33 YR
• Date Report Sent to FDA: 01/01/2005