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

Model Number	501-016
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	05/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A lead extraction procedure commenced to remove a right ventricular (rv) and a right atrial (ra) lead due to bacteremia and cied system/pocket infection.The traction platform manufacturer/type is unk.Using a spectranetics 16f glidelight laser sheath and a spectranetics large visisheath dilator sheath to remove the rv lead, advancement was made past the superior vena cava (svc); however the patient''s blood pressure dropped.Transesophageal echocardiography (tee) detected an effusion in the area of the rv.Rescue efforts began immediately, including pericardiocentesis, bypass and sternotomy.An svc perforation was discovered and repaired, and the rv lead was removed through the ra and pocket, in two pieces.The patient survived the procedure.The surgeon stated the perforation looked more like a hole than a tear, so he thought the bevel of the visisheath likely caused the perforation.The ra lead was also removed during the procedure.This report captures the visisheath in use in the svc when the perforation occurred, requiring intervention.There was no alleged malfunction of any spectranetics devices in use during the procedure.
Additional Manufacturer Narrative
Patient's weight unk.Device lot number, expiration date unk.Partial udi populated.The device was discarded, thus no investigation could be completed.Device manufacture date unk because lot number unk.Great vessel perforation is a known risk of complication with use of the visisheath.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.

• Brand Name: 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): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-2465
• MDR Report Key: 16988796
• Report Number: 1721279-2023-00084
• Device Sequence Number: 12460154
• Product Code: DRE
• UDI-Device Identifier: 00813132020378
• UDI-Public: 00813132020378
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 05/23/2023

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: 501-016
• Device Catalogue Number: 501-016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/23/2023
• 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: MEDTRONIC 4574 RA PACING LEAD; MEDTRONIC 6947 RV ICD LEAD; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; TRACTION PLATFORM MANUFACTURER/TYPE UNK
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White