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

Model Number	545-513
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Great Vessel Perforation (2152)
Date of Event	10/02/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
H3): the tightrail was not returned, thus no returned product investigation was performed.H6): great vessel perforation and death are known risks of complication with the use of the tightrail device.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 in 1990, and an ra and rv lead, implanted in 2019.Spectranetics lld ez lead locking devices (lld ezs) were inserted into each lead to provide traction.Beginning with a spectranetics 14f glidelight laser sheath, the ra and rv leads (implanted in 2019) were extracted successfully.Next, upsizing to a 16f glidelight and then switching to a spectranetics 13f tightrail rotating dilator sheath, the rv lead (implanted in 1990) was removed.Then, using the 13f tightrail on the remaining ra lead (implanted in 1990), advancement was made through the subclavian and innominate regions, and progressed farther through binding sites in the superior vena cava (svc).Once through the binding, the ra lead dislodged, and the patient's blood pressure dropped.Rescue efforts began, including rescue balloon, medications, and sternotomy.A 1 cm perforation to the right atrium was discovered and repaired (mdr #3007284006-2024-00204).However, while closing the patient's chest, a hematoma and two small perforations in the svc were detected (mdr #3007284006-2024-00205).Attempts were made to repair the two perforations; however, the patient's tissues were friable, and extended into one large perforation.The patient went into disseminated intravascular coagulation (dic), and further intervention commenced, including administration of blood and placing the patient on pump.The svc perforation kept extending while repair attempts continued, and despite extensive rescue efforts, the patient did not survive.This report captures the 13f tightrail in use when the svc perforations occurred, requiring intervention but resulting in death.There was no alleged malfunction of any spectranetics devices in use during the procedure.

• Brand Name: TIGHTRAIL ROTATING DILATOR SHEATH
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-2465
• MDR Report Key: 20411101
• Report Number: 3007284006-2024-00205
• Device Sequence Number: 18122864
• Product Code: DRE
• UDI-Device Identifier: 00813132021658
• UDI-Public: (01)00813132021658(17)260702(10)FRJ24G02A
• Combination Product (Y/N): N
• 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): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/09/2024

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: 07/02/2026
• Device Model Number: 545-513
• Device Catalogue Number: 545-513
• Device Lot Number: FRJ24G02A
• 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: 10/02/2024
• Initial Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/02/2024
• 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: BIOTRONIK SOLIA RA PACING LEAD; BIOTRONIK SOLIA RV PACING LEAD; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LLD EZ LEAD LOCKING DEVICES; ST. JUDE MEDICAL 1018T RA PACING LEAD; ST. JUDE MEDICAL 1226T RV PACING LEAD
• Outcome Attributed to Adverse Event: Death; Life Threatening
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American