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

Model Number	RH*5BL3520A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	11/06/2019
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 9411307
• Report Number: 2243441-2019-00115
• Device Sequence Number: 2929762
• Product Code: DQO
• UDI-Device Identifier: 04987350700063
• UDI-Public: 04987350700063
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/04/2019
• Report Date (Section F): 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
• Operator of Device: Health Professional
• Device Model Number: RH*5BL3520A
• Device Catalogue Number: 40-5021
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/07/2019
• Event Location: Hospital
• Date Report to Manufacturer: 11/08/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: JACKY CATH; POWER INJECTOR
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 57 YR
• Date Report Sent to FDA: 12/04/2019