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

Model Number 545-513

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Great Vessel Perforation (2152); Cardiac Perforation (2513)

Event Date 12/05/2023

Event Type  Injury  

Event Description

A lead extraction procedure commenced to remove 2 right atrial (ra) leads (one capped, one active), a right ventricular (rv) lead and a left ventricular (lv) lead due to bacteremia.Spectranetics lead locking devices (llds) were inserted into each lead to provide traction.Beginning with a spectranetics 13f tightrail sub-c rotating dilator sheath on the active ra lead, an extreme amount of calcium was noted in the subclavian region, but advancement was successful.Next, a 13f tightrail (long) with the tightrail's outer sheath was used to advance around the curve of the superior vena cava (svc).As the physician was applying traction and advancing the tightrail, the scrub tech was controlling the tightrail's outer sheath, and reportedly jammed it forward.The ra lead released and the patient's condition deteriorated.Rescue efforts began immediately, including sternotomy.A perforation from the ra up into the svc was discovered and repaired.It is unk if the remaining three leads were removed.The patient survived the procedure.This report captures the 13f tightrail (long) outer sheath which likely caused the perforation, requiring intervention.There was no alleged malfunction of any spectranetics devices in use during the procedure.

Manufacturer Narrative

A4): patient's weight unk.B6): relevant tests/laboratory data unk.B7): other relevant history unk.D4): device lot number, expiration date unk.Partial udi populated.H3): the device was discarded, thus no investigation could be completed.H4): device manufacture date unk because lot number unk.H6): great 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.

Manufacturer Narrative

Udi related data quality updates only.D4): correction: removing primary di number from udi# field.The lot number was not provided, thus an entire udi# is unavailable.G3): on 09jul2024, the manufacturer received fda email correspondence identifying a discrepancy in the udi information (section d of the initial mdr).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
• Type of Device: 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 ; 719447-246
• MDR Report Key: 18370316
• MDR Text Key: 331048412
• Report Number: 3007284006-2023-00096
• Device Sequence Number: 1
• Product Code: DRE
• UDI-Device Identifier: 00813132020897
• UDI-Public: 00813132020897
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/22/2024

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
• Device Operator: Health Professional
• Device Model Number: 545-513
• Device Catalogue Number: 545-513
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/20/2023
• Supplement Dates Manufacturer Received: 07/09/2024
• Supplement Dates FDA Received: 07/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MEDTRONIC 4574 ACTIVE RA PACING LEAD.; MEDTRONIC 5024 RV PACING LEAD.; SPECTRANETICS 13F TIGHTRAIL SUB-C DILATOR SHEATH.; SPECTRANETICS LEAD LOCKING DEVICES.; ST. JUDE MEDICAL 1388T CAPPED RA PACING LEAD.; ST. JUDE MEDICAL 1458Q LV LEAD.
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White