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 03/20/2024

Event Type  Injury  

Event Description

A lead extraction procedure commenced to remove a right ventricular (rv) lead due to an improving ejection fraction (ef), after the lead was placed for postpartum cardiomyopathy.The patient no longer wanted the device or the lead after her condition improved.Prior to the insertion of any traction device, the lead pulled out approximately halfway but did not fully extract, with the tip of the lead located at the superior vena cava (svc)/right atrial (ra) junction.A spectranetics lld ez lead locking device (lld ez) was inserted into the lead to provide traction.Beginning with a spectranetics 11f tightrail sub-c rotating dilator sheath, advancement was made through the clavicle.Then, a 13f tightrail (long) was used, making steady progress to the distal end of the rv coil.After significant effort, the tightrail advanced past the distal coil; however, the patient''s blood pressure dropped and an effusion was detected via transesophageal echocardiography (tee).Rescue efforts began, including sternotomy and bypass.An approximately 3/4 inch svc/ra junction perforation was discovered and repaired, and the rv lead was extracted from the pocket post-sternotomy.The patient survived the procedure.This report captures the 13f tightrail (long) in use when the perforation occurred, requiring intervention.There was no alleged malfunction of any spectranetics devices in use during the procedure.

Manufacturer Narrative

A2): patient''s date of birth unk.H3): the device was discarded, thus no investigation could be completed.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.

• 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: 19091234
• MDR Text Key: 339987633
• Report Number: 3007284006-2024-00077
• Device Sequence Number: 1
• Product Code: DRE
• UDI-Device Identifier: 00813132021658
• UDI-Public: (01)00813132021658(17)251214(10)FRJ23M14A
• 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
• Report Date: 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2024
• 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
• Device Lot Number: FRJ23M14A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2023
• 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: BIOTRONIK PLEXA PROMRI S DX RV ICD LEAD; SPECTRANETICS 11F TIGHTRAIL SUB-C DILATOR SHEATH; SPECTRANETICS LLD EZ LEAD LOCKING DEVICE
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Weight: 76 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American