MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA OPTITORQUE ANGIOGRAPHIC CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number RH*5BL3520A

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

Patient Problem Blood Loss (2597)

Event Date 11/06/2019

Event Type  Injury  

Event Description

The user facility reported that the involved optitorque angiographic catheter device did not fail; however, patient injury occurred.This physician was performing a radial left heart catheterization.He always uses the jacky cath for the left ventricular angiogram (lv gram) as well as imaging the coronary arteries.While injecting through the cath for the lv gram, the myocardium came in contact with the tip of the cath during a systolic contraction.The power of the injection broke through the myocardium and filled the pericardial space with contrast.The wall of the lv was compromised and required immediate attention.A pericardiocentesis was performed and then the patient was later taken to the operating room.The surgeon opened the anterior chest wall and placed a single suture to close the compromised myocardium.The patient did fine with the surgery and was then transferred to the intensive care unit for recovery.A power injector was used for the lv injection.The setting was at a flow rate of 10cc per second, for a total of 20cc delivered.The psi limit was at 1000.An accurate estimate of blood loss could not be provided.Additional information was received on 08nov2019.The wall of the heart hugged the tip of the catheter during systole, and the injection power caused the myocardium to break.They could not quantify blood loss as the patient went to surgery right after and blood was drained off the pericardial sac.The only equipment used in addition was the pericardial synthesis tray to drain fluid off.

• Brand Name: OPTITORQUE ANGIOGRAPHIC CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 9411307
• MDR Text Key: 169120948
• Report Number: 2243441-2019-00115
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 04987350700063
• UDI-Public: 04987350700063
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/04/2019

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?: Yes
• Device Operator: Health Professional
• Device Model Number: RH*5BL3520A
• Device Catalogue Number: 40-5021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/04/2019
• Distributor Facility Aware Date: 11/07/2019
• Event Location: Hospital
• Date Report to Manufacturer: 11/08/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: JACKY CATH; POWER INJECTOR
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR