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  

Manufacturer Narrative

Expiration date: unknown due to unknown lot number.Implanted date: device was not implanted.Explanted date: device was not explanted.Device manufacture date: unknown due to unknown lot number.The involved device was not returned for evaluation.Therefore, the investigation was based on user facility information and evaluation of the retention sample.Visual inspection of a retention sample of the involved product code did not find any anomaly in the distal section, such as a crush, protrusion, or burr in the distal section the production lot number was not provided by the user facility, which prevented a meaningful review of the device history record.In the manufacturing process, the product is subjected to the following inspections on a sampling basis after the assembling process: the strength of the distal section against compressing force and visual inspection for any protrusion or burrs in the distal section.Ifu states: insert guide wire of appropriate size into the catheter through its hub and advance the wire to approximately 5 cm beyond the catheter's distal tip.It should be used by a physician who is well trained in manipulation and observation under fluoroscopy.With no device return the exact cause of the reported event cannot be definitively determined based on the available information.Please see mdr 2243441-2019-00115 for the importer report.(b)(4).

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
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: theresa mussaw ; reg. no. 2243441; 950 elkton blvd; elkton, MD 21921 ; 8002837866
• MDR Report Key: 9411309
• MDR Text Key: 181620857
• Report Number: 9681834-2019-00205
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 04987350700063
• UDI-Public: 04987350700063
• 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: company representative,health
• 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

• Date FDA Received: 12/04/2019
• 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
• Date Manufacturer Received: 11/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR