MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA OPTITORQUE ANGIOGRAPHIC CATHETER

Model Number N/A

Device Problem Bent (1059)

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

Event Date 07/14/2015

Event Type  Injury  

Event Description

The user facility reported the radifocus optitorqus device became kinked during a coronary angiography procedure.Follow up communication with the user facility reported the following information: the actual device became kinked during cag (coronary angiography) procedure.Right radial approach with severe tortuousness in the cubital vessel.As the distal end of the device would not come up close to valsalva sinus.The doctor checked the cubital vessel under fluoroscope.Found that the actual device had become kinked into a s-letter crank like form.It was very difficult to withdraw the actual device with very high resistance perceived.A snare was inserted by the femoral approach.It caught the distal segment of the actual device.Straightened it and withdrew it out of the patient successfully on (b)(6) 2015.No known impact to the patient.

Manufacturer Narrative

Results - bent.The actual sample was returned to the manufacturing facility for evaluation.Visual inspection upon receipt found that the shaft had been distorted on approximately 558mm - 577mm from the distal end.Magnifying inspection of the distorted segment did not reveal any visual anomaly, such as a cut or dent, which could be a trigger of the generation of the distortion.There was no other anomaly in the appearance.Magnifying inspection of the lumen at the hub and at the distal end did not reveal any anomalies or defects.The inner and outer diameters were measured on the undamaged segment and confirmed to meet manufacturer specifications, being comparable to those of the current product sample.Kink resistance was evaluated on the undamaged segment and confirmed to meet manufacturer specifications being comparable to that of the current product sample.Torque resistance was evaluated on the undamaged segment and confirmed to meet manufacturer specifications being comparable to that of the current product sample.A review of the device history record and the product release decision control sheet of the involved product code/lot number combination confirmed that there were no production-related problems or discrepancies in the inspection result.A review of the complaint files confirmed the involved product code/lot number combination has not be reported previously.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, during the investigation the actual device did not show any inherent deficiencies in the product strength.As a cause of this incident, the below scenario can be inferred.Based on the fact that the patient's cubital vessel was tortuous, it is likely that a minute kink or crush was generated on the actual device due to some factor(s) while the actual sample was passing through the tortuous vessel.Subsequently, when the actual sample was subjected to some manipulations, including torque, pushing and pulling manipulations, with the presence of the kink or crush on it, the kink or crush played a role of a trigger of the generation of torque force concentrated on a specific segment, resulting in the generation of the distortion on the shaft.(b)(4).All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.(b)(4).

• Brand Name: OPTITORQUE ANGIOGRAPHIC 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; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer Contact: kathleen little ; reg. no. 2243441; 2101 cotton tail ln.; summerset, NJ 08873 ; 8002837866
• MDR Report Key: 4963365
• MDR Text Key: 6194853
• Report Number: 9681834-2015-00173
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/14/2015,08/04/2015

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: 03/31/2018
• Device Model Number: N/A
• Device Catalogue Number: RH-5JR4000
• Device Lot Number: 150421
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2015
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 07/14/2015
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/14/2015
• Initial Date Manufacturer Received: 07/14/2015
• Initial Date FDA Received: 08/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2015
• 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 Outcome(s): Other