MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION HEARTRAIL III GUIDING CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	40-6381
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	09/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that a dissection of the right coronary artery (rca) occurred.After three stents were deployed, the dissection occurred.The patient was hemodynamically stable and transferred to the or (operating room) for cabg (coronary artery bypass graft).The original intended procedure was a percutaneous coronary intervention of the right coronary artery.The stent(s) used were, 3.0 mm x 48 mm boston scientific synergy des, 3.0 mm x 12 mm boston scientific synergy des, and 3.0 mm x 8 mm boston scientific synergy des.An intracoronary vascular ultrasound of the rca was performed.The device did not work properly (e.G., broke, could not get it to work or stopped working).
Additional Manufacturer Narrative
A1: patient identifier: requested, not provided.A2: date of birth: requested, not provided.A5: ethnicity: requested, not provided.D4: product code: likely 40-6381.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E1: phone number: (b)(6).The actual sample has not yet been received by ashitaka factory.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.In accordance with the medwatch, it was reported that the involved product was a heartrail iii ikari right 6fr ir 1.5 100cm and the lot was 230323; from this, it was likely that the involved product code was 40-6381.Review of the manufacturing history record and the shipping inspection record of the involved product code/lot number combination confirmed that there were not any anomalies in them.A search of the complaint file found no other similar report with the involved product code/lot number combination from other facilities.Terumo medical products (tmp) (importer) registration no.(b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).
Additional Manufacturer Narrative
This report is being sent as follow-up no.2 to provide additional information to section b5 and the lot number in section d4.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the device return date in section d9, update section h3, and to provide the completed investigation results.The returned product was a heartrail iii (product code: gc-u6ir150n/40-6381).Appearance confirmation: the distal end of the actual sample had been crushed.There were gaps and roughness on the inner surface of the distal end of the actual sample (electron microscope).No reinforcement was exposed at the distal end of the actual sample (microscope and electron microscope).Function confirmation: the hardness (resistance against push-in force) of the shaft near the distal end was measured and compared with that of current products (n=3).No anomaly in hardness that could be the cause of vascular dissection was observed.The investigation results showed no anomaly in the manufacturing records, product inspection records, or the hardness of the distal end of the actual sample.The following events were considered to have occurred at the distal end of the actual sample, but a causal relationship to the vascular dissection could not be determined.Abrasion force was applied to the actual sample while some hard object (e.G., concurrently used device) was in contact with the inner surface, which resulted in the gaps and roughness on the inner surface.Excessive compressive force was applied to the distal end causing the crush.Ashitaka factory has been making efforts in maintaining the quality of the product by performing the following work and control.Before the packaging process, 100% visual inspection of the catheter is performed to confirm that there is no anomaly such as a kink or crush.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 or crushing.After 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.The instructions for use (ifu) of this product contains the following information: "directions for use/5-1/cautions when advancing the tip of the guiding catheter into the coronary artery, do not advance it beyond the distal end of the dilatation catheter.Advancing the guiding catheter beyond the distal end of the dilatation catheter will increase the risk of damaging the coronary artery." "directions for use/5-1/cautions carefully manipulate the catheter if the lesion is around the coronary ostium.".
Additional Manufacturer Narrative
This report is being submitted as follow up no.3 to provide a correction to section d4: udi, d4: catalog number, and d4: model number.

• Brand Name: HEARTRAIL III GUIDING CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: gina digioia ; 950 elkton blvd; elkton, MD 21921 ; 6402040886
• MDR Report Key: 18118601
• Report Number: 9681834-2023-00223
• Device Sequence Number: 12647540
• Product Code: DQO
• UDI-Device Identifier: 04987350383259
• UDI-Public: (01)04987350383259(17)260228(10)230323
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K113335
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/13/2023

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 Expiration Date: 02/28/2026
• Device Model Number: 40-6381
• Device Catalogue Number: GC-U6IR150N
• Device Lot Number: 230323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2023
• Supplement Date Received by Manufacturer: 11/22/2023; 11/30/2023; 07/19/2024
• Initial Report FDA Received Date: 11/13/2023
• Supplement Report FDA Received Date: 12/08/2023; 12/29/2023; 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 106 KG
• Patient Race: White