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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the glidecath device involved was used to treat a patient with in-stent restenosis of the left superficial femoral artery (sfa).The entire length of the sfa was stented.The 4fr 65 centimeter angled glidecath was used to access the proximal portion of the stent over a 0.035" 260 centimeter glidewire advantage.The glidecath got stuck in a proximal lesion within the stent, and a large portion of the catheter sheared off when it was attempted to be removed.About half of the glidecath was sheared.The segment that sheared off was easily snared and retrieved from the patient.There was no effect to the patient.The outcome of the procedure was successfully completed.There was no patient injury or surgical intervention required.Additional information was received on 01 mar 2022: the patient was in stable condition.All sheared catheter pieces were retrieved from the patient.Hemostasis was achieved by manual compression.There was no blood loss.The catheter was damaged and the catheter was in two pieces when removed.
Additional Manufacturer Narrative
Implanted date: device was not implanted.Implanted date: device was not implanted.Occupation: registered technologist (rt r).The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.A review of the manufacturing record and the product release decision control sheet confirmed that there were not any indications of anomaly in them.A search of the complaint file found no other similar report with the involved product code/lot number combination from other facilities.Based on the investigation result, no anomaly was found in the records.It was likely that the actual product was sheared off due to excessive pulling force applied for some reason.However, since the actual sample was not returned for the investigation, the cause of occurrence could not be clarified.Ashitaka factory assures the quality of this product by performing following inspections: i) after the shaft is molded on the core wire whose outer diameter is controlled, the core wire is removed to assure the inner diameter of shaft.Ii) before the packaging processes, 100 percent magnifying inspection is performed to assure that there is no anomaly including a breakage on the catheter.Iii) in the packaging and cartoning processes, dedicated tools and containers are used to protect the product and to prevent generation of a breakage.The ifu states: "warning - never advance or withdraw an intraluminal device against resistance until the cause of resistance is determined by fluoroscopy.Failure to exercise proper caution may result in damage to the vessel or catheter.Separation of the catheter may occur requiring retrieval in some cases." (b)(4).

• Brand Name: TERUMO GLIDECATH CATHETER
• Common Device Name: 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: stephanie handy ; reg. no. 2243441; 950 elkton blvd; elkton, MD 21921 ; 9499890491
• MDR Report Key: 13892641
• Report Number: 9681834-2022-00037
• Device Sequence Number: 1779387
• Product Code: DQO
• UDI-Device Identifier: 04987350772190
• UDI-Public: 04987350772190
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K915414
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/24/2022

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: 03/31/2023
• Device Model Number: N/A
• Device Catalogue Number: CG415
• Device Lot Number: 200416
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2022
• Initial Report FDA Received Date: 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 260CM 0.035" GLIDEWIRE ADVANTAGE; 4F 11CM CORDIS AVANTI SHEATH
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 39 KG