MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS 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	Great Vessel Perforation (2152); Cardiac Perforation (2513)
Date of Event	02/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A lead extraction procedure commenced to remove a capped right atrial (ra) and a malfunctioning right ventricular (rv) lead, leaving an active ra lead within the patient, not targeted for extraction.Spectranetics lead locking devices (llds) were inserted into the capped ra and rv leads, and suture was used as well, to provide traction.The ra lead was successfully removed using spectranetics 9f and 11f tightrail rotating dilator sheaths.While using the 11f tightrail to attempt removal of the rv lead, the physician encountered stalled progress around the turn of the superior vena cava (svc), therefore the tightrail was removed from the patient, with the intention of using a laser catheter.However, prior to the use of another device, the patient''s blood pressure dropped.Rescue efforts began, including rescue balloon and sternotomy.An svc/ra junction perforation was discovered and repaired.During removal of the rv lead post-sternotomy, the perforation re-opened again, and was repaired.The rv lead was successfully removed and the patient survived the procedure.This event captures the 11f tightrail 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
Patient''s weight unk.The device was discarded, thus no investigation could be completed.Vessel and cardiac perforations are known risks 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: SPECTRANETICS TIGHTRAIL ROTATING 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: 16517483
• Report Number: 1721279-2023-00043
• Device Sequence Number: 14275402
• Product Code: DRE
• UDI-Device Identifier: 00813132021641
• UDI-Public: (01)00813132021641(17)241220(10)FRK22M20A
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/09/2023

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 Expiration Date: 12/20/2024
• Device Model Number: 545-511
• Device Catalogue Number: 545-511
• Device Lot Number: FRK22M20A
• 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: 03/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2022
• 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 350973 RA PACING LEAD; BIOTRONIK 350974 RV PACING LEAD; BIOTRONIK 377176 RA PACING LEAD; SPECTRANETICS 9F TIGHTRAIL DILATOR SHEATH; SPECTRANETICS LEAD LOCKING DEVICES
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White