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  

Manufacturer Narrative

A1: patient identifier: requested, not provided.A2: date of birth: requested, not provided.A5: ethnicity: requested, not provided.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.1.Since the actual sample was not returned, investigation of it could not be performed.2.Following investigation was performed on the factory-retained product with the involved product code/lot number.Appearance: no anomaly such as damage was found leak test: after filling the catheter with colored water and submerging the distal end of catheter in the colored water, the colored liquid was aspirated or pressurized with a syringe from the hub side.No air mixing or leakage of the colored liquid was found.3.History investigation of the product with the involved product code/lot number no anomaly was found in the manufacturing record and the shipping inspection record.No other similar report was found in the past.(cause of occurrence) no anomaly was found in the manufacturing record, the shipping inspection record, or in the factory-retained product with the involved product code/lot#, and no causal relationship with this incident was found.(countermeasure) ashitaka factory manufacturing process assures the quality of this product by performing following work and inspections.When adhering the shaft and hub, 100% inspection is performed to confirm that the distal end of shaft is abutting the end of hub, and that the adhesive covers a certain length or more around the entire circumference.In the packaging and cartoning processes, dedicated tools and containers are used for handling this product to protect it and to prevent it from kinking.Before the packaging process, 100% visual inspection of the catheter is performed to confirm that there is no anomaly such as a crush or kink.Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.

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)(6), brand name :optitorque, age of device : 1days, single use device : [no], available for evaluation? [no], procode : dqo, and 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)(6), brand name :a2000 multi-use syringe kit, age of device : 1days, single use device : [no], available for evaluation? [no], procode : dxt, and 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)(6), brand name :bt2000 automated manifold kit, age of device : 1days, single use device : [no], available for evaluation? [no], procode : dxt, and 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)(6), and 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
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: gina digioia ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 6402040886
• MDR Report Key: 17795781
• MDR Text Key: 324001982
• Report Number: 9681834-2023-00188
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150232
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• 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 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
• Date Manufacturer Received: 08/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/03/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: INJECTOR AND SYRINGE, ANGIOGRAPHIC
• Patient Outcome(s): Other; Death
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 92 KG
• Patient Race: White