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

Catalog Number MC-PP27131

Device Problems Physical Resistance (2578); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/19/2017

Event Type  malfunction  

Manufacturer Narrative

510(k): k033913.The actual device has been returned for evaluation.Visual inspection revealed the following: the catheter and guide wire had been combined with each other.The guide wire had two kinks respectively at approximately 830mm and 836mm from the distal end of the device, forming a zigzag shape with the interval between the two kinks being approximately 6mm.The catheter had been fractured at approximately 523mm from the distal end of the device.A fractured piece of the catheter, approximately 6mm in length was found to be inserted over the guide wire between the two kinks on the guide wire the segment of the catheter distal to the fracture located at the guide wire's kink at approximately 830mm from the distal end of the guide wire was not returned to the factory.The total length of the catheter was found to be approximately 529mm.When compared with the retention sample of the involved product code whose total length is approximately 1300mm, the actual catheter sample is missing the segment approximately 771mm in length.Magnifying inspection of the kinks on the guide wire found that the urethane outer layer had been damaged with the core wire exposed on the segment adjacent to the kinks.Further magnifying inspection of the guide wire did not find any anomaly, such as damaged urethane outer layer, on the remainders of the device.Magnifying inspection of the catheter did not reveal any other anomaly, such as an elongated segment, then the fractures.The outside diameters of the guide wire and the catheter were measured on the undamaged segments and both were verified to meet the specifications.Reproductive testing was performed.A product sample of the involved product code, in the state of the guide wire placed in the catheter, was inserted in a guiding catheter sample (glidecath with a two-way stopcock attached to the proximal end).In this state, the two-way stopcock was closed and then opened.As a result, the sample was found not to be able to be advanced any farther in the glidecath.The sample was withdrawn from the glidecath.It was found that the guide wire had been kinked at two locations, with a fractured piece of the catheter placed between the kinks.The kinks were found to form a zigzag shape with the interval between the two kinks being approximately 6mm.Around the kinks the urethane outer layer was found to have been damaged with exposure of the core wire.A review of the device history record and the shipping inspection record were unable to be performed due to the involved unknown lot number.The labeling does address the potential for such an event in the instruction-for-use (ifu) with statements such as the following: if the guiding catheter is fitted with a stopcock, do not close the stopcock with the micro catheter system inside the guiding catheter.The micro catheter system may be broken.There is no evidence that this event was related to a device defect or malfunction.Based off the investigation, it is likely that the actual sample (the combination of the catheter and guide wire) in the state of being inserted in the involved guiding catheter which had a two-way stopcock at its proximal end was subjected to pinching force by the manipulation of the involved two-way stopcock.As the result, the guide wire got kinked and the catheter was fractured and farther advancement of the actual sample in the involved guiding catheter.However, the exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).

Event Description

The user facility reported difficulties with the involved progreat device.The procedure was an embolization of the bronchial artery.The tissue was already scarred, and the progreat got stuck at some point, and could not be advanced any further.There was resistance, and the doctor then pulled the progreat out and replaced it with another 2.7f, 130cm length which successfully reached the target area.There was no harm to the patient.

• Brand Name: PROGREAT CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer Contact: terry callahan ; reg. no. 2243441; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 7337177
• MDR Text Key: 102353048
• Report Number: 9681834-2018-00013
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K033583
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MC-PP27131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/14/2018
• 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
• Patient Age: 36 YR