MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA PROGREAT CATHETER; CORONARY GUIDING CATHETER

Catalog Number MC-PP27131

Device Problems Fluid/Blood Leak (1250); Hole In Material (1293); Kinked (1339)

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

Event Date 04/08/2014

Event Type  malfunction  

Event Description

The user facility reported that during an embolisation procedure, the progreat catheter kinked and leakage occurred.There was reportedly no harm to the patient.

Manufacturer Narrative

(b)(4).Terumo has received the actual device for evaluation; however, the investigation has yet to be completed.A follow-up report will be submitted when the investigation is complete.A retention sample was visually inspected and no anomalies were found which would relate to the reported catheter leakage.A review of the device history record revealed no indication of production related anomalies, and a review of the complaint file found no other report with the involved product code/lot number combination.The device labeling does address the potential for such an event in the warnings / precautions section of the instructions-for-use, which states, "if any resistance is felt in the vessel, do not advance or withdraw the catheter until the cause of resistance is determined.Manipulating the catheter and/or the guide wire against resistance may result in damaging the vessel, the catheter or the guide wire." all available information has been placed on file in quality assurance for appropriate tracking, trending and follow-up.(b)(4).

Manufacturer Narrative

The involved device was returned and evaluated.Visual inspection found that the actual sample had been damaged at approximately 7mm from the proximal end.A leak test was performed on the catheter and a leak was noted on the damaged segment.Magnified inspection of the damaged segment revealed: a rupture located on the outer layer in the circumferential direction exposing the coil; abrasions in the longitudinal direction; and separation of the inner and outer layers that resulted in a gap.Further evaluation using x-ray fluoroscopy revealed cuts on the ruptured inner layer.Electron microscopy of the ruptured area and the segment around it revealed abrasions in the distal direction from the proximal.A review of the device history record revealed no product or manufacturing related anomalies.A search of the complaint file did not find any other report with the involved product code and lot number.While the cause of the reported event cannot be definitively determined based on the available information, the evaluation results indicate that the actual sample had been subjected to pressure from the catheter resulting in the noted abrasions and cuts.Fluid injected through the catheter is thought to have seeped in between the layers through the cuts causing the adhesive material to deteriorate, and the buildup of fluid pressure caused the outer layer to rupture.The device labeling does address the potential for such an event in the instructions-for-use by statements including, "warning: do not pressurize the catheter or advance the guide wire through the catheter when the catheter is kinked or blocked.This may result in breakage of the catheter and damage to the vessels." all currently available information has been placed on file by qa at the manufacturing facility for appropriate tracking, trending and follow-up.

Event Description

This report is being submitted as follow-up # 1 for mfg.Report # 9681834-2014-00124 to provide additional information regarding evaluation of the returned sample.

Manufacturer Narrative

This follow-up report #2 is being submitted to provide updated information based new information provided by the user facility.The initial reported malfunction of kink and leakage was determined not to be reportable.Therefore, this report does not meet the criteria for adverse event reporting.However, because the initial report has already been submitted prior to the additional information being received, this report is being submitted as follow-up to further detail the investigation.This follow up is also being submitted to provide the date the manufacturing facility received additional information regarding the event and/or evaluation of the actual sample.This date was inadvertently omitted in the previous follow-up report.The information provided below lists the date(s) the additional information was received by the manufacturing facility: follow-up #1 = 05/23/2014.

Event Description

This report is being submitted as follow-up #2 for mfg.Report #9681834-2014-00124 to provide the date that additional information was received by the manufacturing facility for follow up # 1 also to include new information provided by the user facility.

• Brand Name: PROGREAT CATHETER
• Type of Device: CORONARY GUIDING 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: 3786043
• MDR Text Key: 20979449
• Report Number: 9681834-2014-00124
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K033913
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/09/2014,05/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2016
• Device Catalogue Number: MC-PP27131
• Device Lot Number: 140207
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/28/2014
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 04/08/2014
• Device Age: 2 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/09/2014
• Date Manufacturer Received: 10/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2014
• 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