MAUDE Adverse Event Report: COOK INC PRESSURE MONITORING SET; DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number N/A

Device Problem Material Separation (1562)

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

Event Date 04/26/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The event is currently under investigation.

Event Description

The catheter broke off at the hub ((b)(4)).A new device was opened and the distal end crumbled ((b)(4)).Additional information was requested.

Manufacturer Narrative

Investigation - evaluation: a review of the documentation, instructions for use (ifu), specifications, and quality control was conducted during the investigation.The complaint device was not returned; therefore no physical examination could be performed.The lot number of the device is not known; accordingly a review of the device history record could not be conducted.Based on the information provided, no product returned, and the results of our investigation; a definitive root cause could not be determined.Measures have been conducted to address this failure mode.Monitoring will continue to be performed for similar complaints.

Event Description

It was reported that during placement of a pressure monitoring set, the catheter broke off at the hub (1820334-2016-01371).A new device was opened and the distal end crumbled.No further information was provided regarding the procedure or patient outcome.

• Brand Name: PRESSURE MONITORING SET
• Type of Device: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 6137614
• MDR Text Key: 61194491
• Report Number: 1820334-2016-01370
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002254
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/05/2017

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 Model Number: N/A
• Device Catalogue Number: C-KPMS-300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2016
• Initial Date FDA Received: 12/01/2016
• Supplement Dates Manufacturer Received: 08/31/2017
• Supplement Dates FDA Received: 09/05/2017
• 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