MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA PROGREAT CATHETER

Catalog Number MCZPC2013ZZH

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/03/2014

Event Type  Injury  

Event Description

The user facility reported that during a trancecatheter arterial chemoembolization (tace) procedure, the progreat device broke.Follow up communication with the user facility reported the following: (1) after a glidewire gt and the actual sample (progreat) were inserted into the loop-shaped segment in the left hepatic artery; (2) it became very difficult to pull them back; (3) when the customer tried to pull back the actual sample broke; (4) the devices were changed to a sniper catheter and an aqua v3 guide wire; (5) the operation continued and was completed successfully; and (6) the customer stated that the patients artery was highly looped and tortuous.

Manufacturer Narrative

The actual sample was returned to the manufacturing facility.The main body of the device and a fractured piece of the shaft were returned for evaluation.They were measured and the detailed results were obtained as follows: (1) distal segment approx.148mm; (2) inner lumen-exposed and stretched segment approx.252mm; (3) stainless steel reinforcement-exposed and stretched segment approx.136mm; (4) stretched shaft segment approx.87mm; and (5) the main body measures approx.385mm.Due to severe damage and elongation on the shaft, it cannot be determined if there is separated and missing part of the shaft.Magnifying inspection obtained the below findings: there was no break on the distal part, the outer and inner layers had been elongated, exposing the stainless steel reinforcement, due to the stainless steel reinforcement having been elongated in the distal direction, only the outer and inner layers remained, and the inner layer had been elongated and exposed.Electron microscopic inspection did not find any cut or scratch which could be a trigger of the fracture on the surface.Magnifying inspection of the distal end of the fractured piece revealed the generation of several scratches.The stainless steel reinforcement on the segment adjacent to the fracture was inspected under electron microscope and found not to have any deformed portion.There is no evidence that this event was related to a device defect or malfunction.Although the exact cause cannot be determined based on the available information, the appearance of the involved sample is most consistent with the actual sample being subjected to a pulling force when the customer tried to pull it back in the proximal direction in the state of its distal segment being stuck in an object due to some factor(s), resulting in the fracture of the shaft.The device labeling does address the potential for such an event by stating in the instructions-for-use: "monitor the manipulation of the microcatheter system in the vessel by confirming the position of the catheter tip/guide wire through a high resolution fluoroscope and a digital subtraction angiography monitor.If any resistance is felt in the vessel, do not advance or withdraw the microcatheter system until the cause of resistance is determined through a high resolution fluoroscope and a digital subtraction angiography monitor.Manipulating the catheter or the guide wire against resistance may result in damaging the vessel, the catheter or the guide wire.If the situation is not solved, withdraw the entire system of the catheter or the guide wire with the guiding catheter." all available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.(b)(4).

Manufacturer Narrative

As stated, this report is being submitted as follow-up # 1 for mfg.Report # 9681834-2014-00340 to provide the correction of the product lot number.

Event Description

This report is being submitted as follow-up # 1 for mfg.Report # 9681834-2014-00340 to provide the correction of the product lot number.

• Brand Name: PROGREAT CATHETER
• Type of Device: CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer Contact: cathleen hargreaves ; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 4356251
• MDR Text Key: 5172741
• Report Number: 9681834-2014-00340
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K033583
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/05/2014,12/23/2014

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
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2016
• Device Catalogue Number: MCZPC2013ZZH
• Device Lot Number: 140804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2014
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/03/2014
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/05/2014
• Initial Date Manufacturer Received: 02/19/2015
• Initial Date FDA Received: 12/23/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2014
• 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
• Treatment: SNIPER CATHETER; GLIDEWIRE GT; AQUA V3 GUIDEWIRE
• Patient Outcome(s): Other