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

Model Number	501-014
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Pleural Effusion (2010); Pneumothorax (2012)
Date of Event	02/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A lead extraction procedure commenced to remove a right ventricular (rv) lead due to non function.A spectranetics lead locking device (lld) was inserted into the rv lead to provide traction.The physician chose to use a spectranetics glidelight laser sheath along with a spectranetics visisheath dilator sheath to attempt lead removal.While lasing in the subclavian/innominate region, the patient''s blood pressure dropped and then returned, so extraction procedure continued.The tools were able to advance to the superior vena cava (svc) when the blood pressure dropped again, then returned.Transesophageal echocardiography (tee) showed no effusion.Rv lead was removed and new lead was implanted.The patient''s blood pressure dropped again, then returned; however, a pleural effusion was seen, along with a pneumothorax of the right lung.The ct surgeon performed a thoracotomy later that day (unk if it was performed on the right or left side), and a hematoma was discovered over the superior aspect of the svc, with no active bleeding.The area was closed, and the patient survived the procedure.This report captures the visisheath device being used closest to the wall of the vessel when the hematoma was discovered.There was no alleged malfunction of any spectranetics devices in use during the procedure.
Additional Manufacturer Narrative
Patient''s date of birth: unk.Patient''s weight: unk.Other relevant history: unk.The device was discarded, thus no investigation could be completed.

• Brand Name: SPECTRANETICS VISISHEATH 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: 13639109
• Report Number: 1721279-2022-00041
• Device Sequence Number: 20134050
• Product Code: DRE
• UDI-Device Identifier: 00813132020361
• UDI-Public: (01)00813132020361(17)231203(10)FVM21M03A
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K092378
• 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): 02/07/2022

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: 12/03/2023
• Device Model Number: 501-014
• Device Catalogue Number: 501-014
• Device Lot Number: FVM21M03A
• 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: 02/07/2022
• Initial Report FDA Received Date: 03/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2021
• 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: MEDTRONIC 6947 RV ICD LEAD; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LEAD LOCKING DEVICE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White