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 Codes	Perforation of Vessels (2135); Great Vessel Perforation (2152); Cardiac Perforation (2513)
Date of Event	11/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A5): patient ethnicity unk b7): relevant history, including preexisting medical conditions unk.H3): the tight rail was not returned, thus no returned product investigation was performed.H6): perforation of vessels, great vessel perforation, and cardiac perforation are known risks of complication with use of the tight rail 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 two right ventricular (rv, one active and one capped) leads, and a right atrial (ra) lead due to non-function.A spectranetics lld lead locking device (lld) was inserted into the active rv lead to provide traction.The procedure began by using a shockwave medical balloon to break up calcium within the superior vena cava (svc) and was removed.Beginning with a spectranetics 14f glidelight laser sheath and spectranetics medium visisheath dilator sheath, advancement was made to the svc, where progress stalled.Switching to a spectranetics 11f tightrail rotating dilator sheath (long), advancement was made through the svc.Then, the 14f glidelight and visisheath were used again, but no further progress was made.Upsizing to a 16f glidelight and visisheath, only slight progress was achieved; therefore, a 13f tight rail was used, reaching the tip of the rv lead, and the lead was extracted.However, the patient's blood pressure dropped, but no effusion was seen via transesophageal echocardiogram (tee).Rescue efforts began, including rescue balloon and sternotomy.A large perforation, extending from the subclavian, innominate, through the svc to the ra, was discovered and repaired.The remaining ra and capped rv leads were removed post-sternotomy, and the patient survived the procedure.This report captures the 13f tight rail 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: 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: 20751410
• Report Number: 3007284006-2024-00226
• Device Sequence Number: 8137219
• Product Code: DRE
• UDI-Device Identifier: 00813132021658
• UDI-Public: (01)00813132021658(17)260509(10)FRJ24E09A
• 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): 11/21/2024

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: 05/09/2026
• Device Model Number: 545-513
• Device Catalogue Number: 545-513
• Device Lot Number: FRJ24E09A
• 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: 11/11/2024
• Initial Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/09/2024
• 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: MEDTRONIC 4004 CAPPED RV PACING LEAD; MEDTRONIC 4262 ACTIVE RV PACING LEAD; MEDTRONIC 4268 RA PACING LEAD; SHOCKWAVE MEDICAL BALLOON; SPECTRANETICS 11F TIGHTRAIL DILATOR SHEATH; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LLD LEAD LOCKING DEVICE; SPECTRANETICS MEDIUM VISISHEATH DILATOR SHEATH
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Race: White