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

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/17/2020

Event Type  malfunction  

Manufacturer Narrative

Occupation- technician iii the actual sample was received for evaluation.Visual inspection revealed that the shaft had been bent at approximately 965mm from the distal end.The shaft had been fractured at approximately 1220mm and at 1275mm from the distal end.The fracture ends were called fracture end-a, fracture end-b, fracture end-c, and fracture end-d.From the carved mark on the hub, sample-c was confirmed to be 2.7 fr.Magnifying inspection of the bent segment did not find a scratch on the surface or breakage in the reinforcing wire.Magnifying inspection of fracture end 1, -2, -3, and -4 found that they all had been compressed.In addition, a lengthwise crack starting from fracture end-3 was found.Electron microscopic inspection revealed that fracture end 1, -2, -3, and -4 had smooth cross section surface.The inspection results from 3.3 and 3.4 indicated that the morphology of each fracture end was very similar to each other, therefore, it was impossible to identify the combination of each fracture end.The inner and outer diameters of the shaft was measured on the intact areas and confirmed to meet the factory's control criteria.Reproductive test was performed on a factory retained progreat and the sample was cut with scissors.As a result, it was confirmed that the cut end was compressed, and the cut surface was smooth.The production lot number was not provided by the user facility, which prevented a meaningful review of the device history record and the shipping inspection record.Ifu states: if any resistance is felt, do not remove the micro catheter system by force.Withdraw the catheter carefully together with the guiding catheter.Removing the catheter by force may result in the catheter breakage/separation, which may necessitate retrieval.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.It is likely that the device came into contact with a sharp-edged object (e.G.Scissors).However, the exact cause of the reported event cannot be definitively determined based on the available information.(b)(4) (importer) registration no.(b)(4).

Event Description

Terumo received an unknown progreat device.Upon the evaluation of the actual device, this report has been deemed reportable.The user facility reported that an mvp-7q was unable to occlude a vessel.The patient was undergoing embolization of a right internal iliac artery before an endovascular aneurysm repair (evar) procedure.Pre-procedure, the vessel was measured to be between 5-7mm.During the procedure, continuous flush was maintained with a syringe through a y-connector.A cross-over procedure was performed using a 4fr terumo glide catheter into the internal iliac artery.The mvp system was prepared as indicated in the ifu, then inserted through the microcatheter into position in the iliac artery.The intended placement location was a straight segment of the artery.At deployment, the catheter was pulled back.The plug was allowed to sit for three minutes before contrast injection was performed, which showed the position was not satisfactory.Two sheathing maneuvers were performed without succeeding in embolization of the vessel.The physician decided to remove the mvp from the patient.The catheter was attempted to be advanced over the mvp for a third time but would not advance.The physician pulled both the catheter and mvp system from the patient together.The procedure was completed without further issue using another manufacturer's coils.The patient condition was reportedly fine.Additional information was received 31mar2020.It was indicated that all devices were prepared as per the instructions for use (ifu).The patient was undergoing surgery for treatment of a gi bleed.It was noted the patient's blood flow and vessel tortuosity were normal.

• Brand Name: UNK PROGREAT
• 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 ; 2837866718
• MDR Report Key: 10475856
• MDR Text Key: 241615685
• Report Number: 9681834-2020-00169
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/01/2020

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/06/2020
• Initial Date FDA Received: 09/01/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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