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

Model Number N/A

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

Patient Problem Cardiac Arrest (1762)

Event Date 08/03/2023

Event Type  Death  

Event Description

Terumo medical received an fda medwatch report # (b)(4).The event description stated: patient was scheduled to undergo a cardiac cath to treat possible coronary artery disease.After all appropriate procedures were done to prepare the contrast injection device, the provider injected dye into the coronary arteries via a right radial catheter.The team member monitoring the procedure, who was recording the fluoroscopy recording noted what appeared to be air in the left anterior descending artery (lad) and circumflex arteries with what appeared to be cardiac standstill.He immediately alerted the provider and other team members, and emergency measures were initiated.The patient was intubated, and cardiac medications were given.The provider placed a second line and proceeded to perform a percutaneous transluminal coronary angioplasty (ptca) in the 100% occluded arteries.This was successful with reducing the blockage to 0%.An intra-aortic balloon pump (iapb) was also placed to assist with cardiac function.However, they were not able to get cardiac function to return on its own.Despite advanced cardiac life support (acls) measures and working on the patient for approximately 90 minutes, he was declared dead.Initially, the provider felt this event occurred due to a possible "clot shower" vs air emboli.Investigation from our side did not identify issues with the acist cvi injector device as our biomed technician examined the device.However, we could not rule out issues with the other parts of the system including the tubing, syringe, or manifold.The devise lot numbers are assumed as these items were in the supply area where this event occurred.Preexisting characteristics that may have contributed to the event: alcohol/drug use; coronary heart disease; hypertension; morbidly obese; stroke; manufacturer response for contrast injection system, acist cvi (per site reporter) waiting for their report.What was the original intended procedure? : treatment of possible coronary artery disease additional information for device #1 : is this a laboratory device or laboratory test? [no] other devices involved device #2 : common device name :catheter, intravascular, diagnostic manufacturer name and address: terumo medical corporation, 950 elkton blvd, elkton, md 21921 model number : 40-5013 catalog number : rh*5tig111a lot number : 230703 expiration date : [jun/2026] unique device identifier :(b)(4) brand name :optitorque age of device : 1days single use device : [no] available for evaluation? [no] procode : dqo is this a laboratory device or laboratory test? [no] device #3 : common device name :injector and syringe, angiographic manufacturer name and address: acist medical systems, inc., 7905 fuller road, eden prairie, mn 55344 catalog number : 014612 lot number : 08423e expiration date : [apr/2024] unique device identifier :(b)(4) brand name :a2000 multi-use syringe kit age of device : 1days single use device : [no] available for evaluation? [no] procode : dxt is this a laboratory device or laboratory test? [no] device #4 : common device name :injector and syringe, angiographic manufacturer name and address: acist medical systems, inc., 7905 fuller road, eden prairie, mn 55344 model number : 014613 catalog number : 014613 lot number : 28822d expiration date : [oct/2023] unique device identifier (b)(4).Brand name :bt2000 automated manifold kit age of device : 1days single use device : [no] available for evaluation? [no] procode : dxt is this a laboratory device or laboratory test? [no] device #5 : common device name :injector and syringe, angiographic manufacturer name and address: acist medical systems, inc., 7905 fuller road, eden prairie, mn 55344 model number : 014645 catalog number : 014645 lot number : 04323d expiration date : [feb/2024] unique device identifier :(b)(4) brand name :angiotouch® kit.

• 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: 17795793
• MDR Text Key: 324003136
• Report Number: 2243441-2023-00031
• Device Sequence Number: 1
• Product Code: DQO
• 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: 09/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 40-5013
• Device Lot Number: 230703
• 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: 09/21/2023
• Distributor Facility Aware Date: 08/22/2023
• Device Age: 1 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/23/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: INJECTOR AND SYRINGE, ANGIOGRAPHIC
• Patient Outcome(s): Death; Other
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 92 KG
• Patient Race: White