MAUDE Adverse Event Report: COOK INC UNKNOWN; DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/05/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
On (b)(6) 2016 the catheter was placed for drainage.On (b)(6) 2016, the catheter got separated at approximately 10cm from the tip.A segment remained in the patient, but was retrieved with forceps and other devices.There have been no adverse effects to the patient reported.
Additional Manufacturer Narrative
Rpn: (b)(4).(b)(4).Initial was filed within the 30 day time frame regardless of corrected date.Investigation - evaluation: a review of the complaint history, drawings, device history record, documentation, quality control and visual inspection of the returned device was conducted during the investigation.Visual inspection of the returned product confirms the device fractured approximately 39.5cm distal of the fitting.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.The description of the event states that the catheter was placed for drainage from (b)(6) 2016.Thirty-six (36) day dwell time exceeds the recommended use in the packaging insert.Based on the information provided, examination of the returned device and the results of our investigation, the root cause of the event is related to off-label use.We will continue to monitor for similar complaints.Per the risk assessment no further action is required.
Event or Problem Description
On (b)(6) 2016 the catheter was placed for drainage.On (b)(6) 2016, the catheter got separated at approximately 10cm from the tip.A segment remained in the patient, but was retrieved with forceps and other devices.There have been no adverse effects to the patient reported.

• Brand Name: UNKNOWN
• Common Device Name: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5619469
• Report Number: 1820334-2016-00260
• Device Sequence Number: 13560875
• Product Code: DQO
• UDI-Device Identifier: 00827002122055
• UDI-Public: (01)00827002122055(17)180420(10)5776547
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2016

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/05/2016
• Device Age: 1 YR
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/08/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/29/2016
• Supplement Report FDA Received Date: 11/17/2016
• 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