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

Model Number N/A

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/13/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This event is currently under investigation.A follow-up report will be generated upon the completion of the investigation.

Event Description

An international customer reported that during a coronary angiogram, the aurous centimeter vessel sizing catheter marking pigtail was inserted into the patient and an attempt was made to perform a run.The catheter was connected to an injector and set on a standard 20 mm at 10 sec run.When the injector commenced to inject, the catheter burst 6 mm from the hub of the catheter outside the patient, emitting iodine and blood.The patient was not affected by this incident.The catheter was exchanged for another one and the procedure continued without further incident.

Manufacturer Narrative

Investigation - evaluation: a review of the complaint history, device history record, documentation, instructions for use (ifu), quality control data, specifications, and visual inspection of the returned device was conducted during the investigation.A used and damaged aurous centimeter vessel sizing catheter was returned for examination.Measuring from the hub the hole is located at approximately 5.5cm.Measuring from hub toward distal end first kink is at approximately 46.3 cm then measuring from first kink the second one was located approximately 32.6 cm.The wire guide was able to advance through the catheter lumen, but areas of resistance were noted.Three kinks are noted at 46.4 cm and 78.8cm from the proximal end and 1.0cm from the distal end.A 2mm diameter hole is present at 5.6cm from the proximal end.No non-conformities were noted when examining the catheter bonds for cracks, bends, flaps, dents, holes, scratches, pitted or rough surfaces that compromise bond integrity.A review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.There is no information regarding the handling of device prior to set up that may have contributed to this device failure.The customer started to use the device when the catheter burst.The catheter was returned with kinks and no kinks were noted by the customer prior to use.There is no information regarding the patient's anatomy that may have contributed to the device failure.Based upon the information provided and the characteristics displayed, it is plausible to suggest that this incident was technique related, product handling related or human anatomy related.Per the quality engineering risk assessment, no further action is required.Monitoring will continue to be performed for similar complaints.However, based on the information provided and the results of our investigation, a definitive root cause could not be determined.

• 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
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6789183
• MDR Text Key: 82602920
• Report Number: 1820334-2017-02116
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00827002119161
• UDI-Public: (01)00827002119161(17)190901(10)7222008
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: N5.0-35-100-P-10S-PIG-CSC-20
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2016
• 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