MAUDE Adverse Event Report: COOK INC AUROUS CENTIMETER VESSEL SIZING CATHETER; DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number N5.0-35-100-P-10S-PIG-CSC-20

Device Problem Material Rupture (1546)

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

Event Date 12/19/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.

Event Description

It was reported that during injection, the aurous centimeter vessel sizing catheter burst near the pump.The complaint device was placed through an unspecified introducer that was placed in the aorta.It was reported that the physician wanted a vascular overview, and chose to use a pressure pump, specifically a pump with the following specifications: 30ml/flow 15ml/s, 1050psi.While injecting contrast media the complaint device burst, resulting in a visible hole measuring 6 cm below the valve.A similar device was then used to complete the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Corrected information: initial reporter also sent report to fda?, narrative: the event occurred during a crossover peripheral transluminal angioplasty (pta).Investigation - evaluation a review of the complaint history, drawings, device history record, documentation, instructions for use (ifu), manufacturing instructions, specifications, quality control, and visual inspection of the returned device was conducted during the investigation.One aurous centimeter vessel sizing catheter was returned in open and used condition; biomatter was present.A hole was present on the catheter shaft approximately 6.3 centimeters (cm) distal from the hub.There was no other observable damage.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that could contribute to this failure mode.A complaint history search revealed that there were no other reported complaints for this lot number.The customer stated that the contrast was injected through the catheter with a pressure pump at a flow rate of 15 milliliters per second and a pressure of 1050 psi.Per the labeling included on the product, the rated pressure for the catheter is 1000 psi.Based on the information provided, examination of the returned product, and the results of our investigation, the root cause for this event was determined to be related to user/ handling as the catheter was utilized with a pressure beyond its intended and indicated use.Per the quality engineering risk assessment, no further action is required.Monitoring will continue to be performed for similar complaints.

• Brand Name: AUROUS CENTIMETER VESSEL SIZING CATHETER
• Type of Device: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7151791
• MDR Text Key: 96124198
• Report Number: 1820334-2017-04629
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00827002119161
• UDI-Public: (01)00827002119161(17)190627(10)7034067
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/16/2018

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
• Device Catalogue Number: N5.0-35-100-P-10S-PIG-CSC-20
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/19/2017
• Initial Date FDA Received: 12/28/2017
• Supplement Dates Manufacturer Received: 02/06/2018
• Supplement Dates FDA Received: 02/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1