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

Model Number	545-511
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Great Vessel Perforation (2152); Pericardial Effusion (3271)
Date of Event	11/14/2022
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 discarded, thus no investigation could be completed.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.
Event or Problem Description
A lead extraction procedure commenced to remove a right atrial (ra) and a right ventricular (rv) lead, implanted for 254 months, and an ra and rv lead, implanted 15 months, due to bacteremia.The two leads implanted for 15 months pulled out with simple traction.Spectranetics lead locking devices (llds) were inserted into the older ra and rv leads to provide traction.Multiple spectranetics devices (14f glidelight laser sheath, medium visisheath dilator sheath, and 11f tightrail rotating dilator sheath) were used as the physician switched back and forth between the leads to attempt advancement through the vasculature.The patient''s blood pressure would periodically drop (treated with medication to stabilize blood pressure), and transesophageal echocardiography (tee) was monitored with no effusion detected.As the 11f tightrail (last device used) was removed from the body, the patient''s blood pressure dropped again, and a 1 cm pericardial effusion was detected on tee.Rescue efforts began immediately, including rescue balloon, chest compressions, bypass and sternotomy.A small superior vena cava (svc) perforation was discovered and successfully repaired.The leads were discovered to be heavily fibrosed on the lateral wall of the svc and had migrated partially extravascular; therefore, the surgeon believed the perforation was unavoidable.Both leads were removed by the surgeon post-sternotomy, and the patient survived the procedure.This report captures the 11f tightrail, the last device in use when the perforation occurred, requiring intervention.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: 15964176
• Report Number: 1721279-2022-00226
• Device Sequence Number: 5574372
• Product Code: DRE
• UDI-Device Identifier: 00813132021641
• UDI-Public: (01)00813132021641(17)230730(10)FRK21G30A
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/12/2022

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 Expiration Date: 07/30/2023
• Device Model Number: 545-511
• Device Catalogue Number: 545-511
• Device Lot Number: FRK21G30A
• 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: 11/14/2022
• Initial Report FDA Received Date: 12/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2021
• 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: ABBOTT 1388TC RA PACING LEAD IMPL. 254 MONTHS; ABBOTT 1388TC RV PACING LEAD IMPL. 254 MONTHS; MEDTRONIC 5076 RA PACING LEAD IMPL. 15 MONTHS; MEDTRONIC 5076 RV PACING LEAD IMPL. 15 MONTHS; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LEAD LOCKING DEVICES; SPECTRANETICS MEDIUM VISISHEATH DILATOR SHEATH
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention; Hospitalization
• Patient Age: 81 YR
• Patient Sex: Male