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

Model Number	40-5023
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device is not available for return; therefore, an investigation could not be performed.History investigation of the product with the included product code/lot #.No anomaly was found in the manufacturing and shipping inspection records.No similar report from other facilities was found.Before the packaging of this product, 100% visual inspection is performed, and then the product is shipped in the unit box to prevent kinking.Since no anomaly was found in the manufacturing and shipping inspection records, it was impossible to clarify the cause.Ashitaka factory assures the quality of this product by performing the following work and controls.Prior to packaging, 100% visual inspection of the catheter is performed to confirm that there are no anomalies such as kinks.During packaging and cartooning processes dedicated containers are used for handling the product to protect the product and to prevent the occurrence of the kink.After being sealed in the peel pack, the product is kept in the state of being hung until it is packed in the unit box so that any undesirable force to the product can be avoided.Instructions for use (ifu) of this product includes the following directions for use and caution: (i) directions for use/ 4.- insert the guide wire alone into the artery.Then proceed to advance the catheter into the artery over the guide wire.(ii) caution - to avoid damage to the catheter after it has been advanced into the vessel, manipulate the guide wire carefully.Particularly when negotiating a bend in the catheter and/or when passing through the catheter's tip.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 or Problem Description
Terumo medical received an fda medwatch report (b)(4).The event description states that the diagnostic radial catheter bent during its use in a patient.It was subsequently removed and replaced, resulting in no harm to the patient.The incident took place in the electrophysiology lab.Additional information was received 19 jun 2024: there was no reported tortuosity that could have affected catheter manipulation within the patient.The patient's condition is currently unknown.

• Brand Name: OPTITORQUE
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 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 ; 4103927218
• MDR Report Key: 19707872
• Report Number: 9681834-2024-00113
• Device Sequence Number: 12471382
• Product Code: DQO
• UDI-Device Identifier: 04987350703521
• UDI-Public: (01)04987350703521(17)260131(10)230203
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K150232
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2026
• Device Model Number: 40-5023
• Device Catalogue Number: RH*5BL3521A
• Device Lot Number: 230203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2024
• Initial Report FDA Received Date: 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown