MAUDE Adverse Event Report: TERUMO MEDICAL CORP. PINNACLE SHEATH; INTRODUCER, CATHETER

Device Problem Difficult to Advance (2920)

Patient Problem Hemoptysis (1887)

Event Date 03/14/2023

Event Type  Injury  

Event Description

During cardiomems implant procedure the physician went past the desired target location with the cardiomems delivery catheter.As the physician pulled the catheter back, both the catheter and abbott command guidewire retreated back in to the main pulmonary artery.When attempting to advance the guidewire and delivery system in to the target vessel again, the guidewire would not advance.Both the guidewire and delivery catheter were then removed from the patient and flushed.A swan ganz catheter was then placed in the target location and the guidewire was advanced again.After multiple attempts in the wrong branch the guidewire was successfully advanced into the correct target location.The swan ganz catheter was then removed and the guidewire retreated with it.The swan ganz was placed in to the target location again and after multiple attempts in the wrong branch the guidewire was again successfully placed in the correct target location.At this time the patient experienced hemoptysis and the procedure was aborted.The patient was suctioned and maintained oxygen saturations throughout the hemoptysis.No further intervention was required to resolve the hemoptysis.The patient was admitted to the icu for observation and released after 24 hours.The 11fr.Pinnacle sheath was used for the procedure.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PINNACLE SHEATH
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORP.
• MDR Report Key: 17488468
• MDR Text Key: 320690593
• Report Number: MW5121167
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/09/2023
• Patient Sequence Number: 1