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

Model Number	N/A
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	04/26/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.(b)(4).The event is currently under investigation.
Event or Problem 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.
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation: a review of the complaint history, device history record, manufacturing instructions, specifications, quality control, and visual inspection of the returned device was conducted during the investigation.The pressure monitoring set was returned for evaluation.Upon visual inspection the device appeared to be pulled apart.The wire was twisted, stretched, and wavy.A document-based investigation evaluation was also performed.There is no evidence to suggest the product was not made to specifications.Review of 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.Based on the information provided and results of the 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 or Problem Description
It was reported that during placement of a pressure monitoring set, the catheter broke off at the hub.A new device was opened and the distal end crumbled (1820334-2016-01370).No further information was provided regarding the procedure or patient outcome.

• Brand Name: PRESSURE MONITORING SET
• Common Device Name: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6137613
• Report Number: 1820334-2016-01371
• Device Sequence Number: 632828
• Product Code: DQO
• UDI-Device Identifier: 00827002134898
• UDI-Public: (01)00827002134898(17)180801(10)NS6138158
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K002254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2017

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-KPMS-300
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/02/2016
• Supplement Date Received by Manufacturer: 08/31/2017
• Initial Report FDA Received Date: 12/01/2016
• Supplement Report FDA Received Date: 09/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention