MAUDE Adverse Event Report: COOK INC CANTATA DUO 2.8 SUPERSELECTIVE MICROCATHETER; KRA CATHETER, CONTINUOUS FLUSH

Model Number	N/A
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: terumo 5 fr.Sim1 hydrophilic catheter, synchro 14 guide wire.Pma/510(k)#: k101450.(b)(4).Investigation evaluation: a review of the complaint history, device history record, instructions for use (ifu), quality control, and specifications of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.From the review of the device master record, the root cause is inconclusive.No additional evaluation of the device was able to be performed since the device was not returned, and images were not provided.Without visual, dimensional, and/or functional testing of the product, we are unable to determine if this complaint was driven by a procedural or device related cause.Nevertheless, the appropriate personnel have been notified of this incident.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported a cantata duo 2.8 superselective microcatheter was placed for a uterine fibroid embolization in a patient with a tortuous anatomy.During the procedure, the physician removed the catheter for assessment.While flushing with saline and contrast solution with a 1 ml syringe, it was observed that a hole had formed in the proximal third of the catheter.The procedure continued with another like catheter which added to the procedure time, but did not result in any adverse effects to the patient.

• Brand Name: CANTATA DUO 2.8 SUPERSELECTIVE MICROCATHETER
• Common Device Name: KRA CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7865119
• Report Number: 1820334-2018-02602
• Device Sequence Number: 19310579
• Product Code: KRA
• UDI-Device Identifier: 10827002238050
• UDI-Public: (01)10827002238050(17)200118(10)8441811
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/11/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/18/2020
• Device Model Number: N/A
• Device Catalogue Number: MCS-2.8-NT2-135-15-HP
• Device Lot Number: 8441811
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2018
• Initial Report FDA Received Date: 09/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1