MAUDE Adverse Event Report: COOK INCORPORATED ONE-TIE COMPRESSION COIL; INSTRUMENTS, SURGICAL, CARDIOVASCULAR

Patient Problems Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Cardiac Perforation (2513); Vascular Dissection (3160)

Event Date 09/20/2023

Event Type  Injury  

Event Description

Lead traction: cook liberator on ra(right atrial) lead, cook liberator and one-tie on rv(right ventricular) lead.(b)(6) 14f glidelight laser sheath was used to advance on rv lead, then 12f glidelight advanced on ra lead.14f glidelight was used again to further advance on rv lead.Then 13f byrd sheath was used to advance on rv lead.Lastly, 16f glidelight was used on rv lead, and lead was extracted.Patient's blood pressure dropped, and rescue efforts began, including noradrenaline and thoracotomy.A coronary sinus perforation was discovered and repaired, and then the ra lead was removed post-thoracotomy.It was confirmed that the 16f glidelight was not used to lase at the coronary sinus or the coronary sinus os.The physician suspected that upon initial implant, the rv lead had prolapsed into the middle cardiac vein (mcv), and the lead's distal tip had bound up on the vessel wall.With countertraction, the lead's tip injured the mcv, and cardiac tamponade developed.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).Ref report: mw5147234.

• Brand Name: ONE-TIE COMPRESSION COIL
• Type of Device: INSTRUMENTS, SURGICAL, CARDIOVASCULAR
• Manufacturer (Section D): COOK INCORPORATED
• MDR Report Key: 17985016
• MDR Text Key: 326310007
• Report Number: MW5147235
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/12/2023

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/20/2023
• Patient Sequence Number: 1
• Treatment: 12F GLIDE LIGHT; 13F BYRD SHEATH; 16F GLIDELIGHT; COOK MEDICAL LIBERATOR LOCKING STYLET; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH
• Patient Age: 25 YR
• Patient Sex: Female