MAUDE Adverse Event Report: SPECTRANETICS CORPORATION 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	Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	11/26/2024
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 non-function.Spectranetics lld lead locking devices (llds) were inserted into each lead to provide traction.Beginning with a spectranetics 14f glidelight laser sheath, the ra lead was successfully removed.Next, the same 14f glidelight was used on the rv lead.Advancement was successful through the ra, where the lead then took a 90-degree bend into the rv.Due to the lead bend and binding noted in the region, the glidelight could not stay coaxial.Switching to a spectranetics 11f tightrail rotating dilator sheath, progress was made around the lead bend, and the tightrail was removed.Using the 14f glidelight again, the rv lead tip dislodged, but the proximal end of the lead was still bound to the rv.After lasing, the lead was freed and extracted; however, the patient¿s blood pressure dropped.A pericardial effusion was noted via transesophageal echocardiogram (tee), and rescue efforts began immediately, including pericardiocentesis and rapid infusion, which stabilized the patient.Then, a pericardial drain was placed, but the blood pressure dropped again, and the drain filled with blood.Rapid infusion was given, and a sternotomy was performed.A small perforation in the ra free wall, next to the inferior vena cava (ivc), was discovered and repaired, and the patient survived the procedure.The physician believes that the tightrail caused the ra perforation.This report captures the 11f tightrail device in use when the perforation occurred, requiring intervention.There was no alleged malfunction of any spectranetics devices in use during the procedure.
Additional Manufacturer Narrative
A2): patient date of birth unk a4): patient weight unk a5): patient ethnicity unk a6): patient race unk b7): other relevant medical history is unk.H3): the tightrail was discarded, thus no returned product investigation was performed.H6): cardiac perforation is a known risk of complication with 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.

• 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: nicole worford ; 9965 federal drive; colorado springs, CO 80921 ; 719447-2465
• MDR Report Key: 20898304
• Report Number: 3007284006-2024-00237
• Device Sequence Number: 5004142
• Product Code: DRE
• UDI-Device Identifier: 00813132021641
• UDI-Public: (01)00813132021641(17)250411(10)FRK23D11A
• 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): 12/10/2024

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: 04/11/2025
• Device Model Number: 545-511
• Device Catalogue Number: 545-511
• Device Lot Number: FRK23D11A
• 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: 11/26/2024
• Initial Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/11/2023
• 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: SPECTRANETICS 14F GLIDELIGHT LASER SHEATHS; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LLD LEAD LOCKING DEVICES; ST. JUDE MEDICAL 2088TC RA PACING LEAD; ST. JUDE MEDICAL 2088TC RV PACING LEAD
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 60 YR
• Patient Sex: Male