MAUDE Adverse Event Report: COOK INC SAFE-T-J FIXED CORE WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/13/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
(b)(4)."a j wire was used during a ct guided pancreatic drain insertion on sunday ((b)(6) 2016).A small foreign body was noted in the collection when reviewing the scans the following day.It was not noticed that part of the wire was missing at any point in the procedure post removal of the wire and it has been noted that the j shape was still intact.Upon reviewing the images the only plausible explanation at this stage is that the distal end of the j-wire snapped whilst the drain was being formed.It is unlikely to cause any harm as it¿s in the collection.A plan has been discussed to remove it safely.The j-wire removed from the patient is believed to be in an almost full large sharps bin which has been sealed and labeled." no additional information was available at the time of this report.
Additional Manufacturer Narrative
A review of the complaint history, device history record, manufacturing instructions, specifications, and quality control 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 was performed.There is no evidence to suggest the product was not made to specifications.Review of the device history record shows no nonconforming events that would contribute to this failure mode.Based on the information provided, no product returned, and the results of the investigation; a definitive root cause could not be determined.Per the quality engineering risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.

• Brand Name: SAFE-T-J FIXED CORE WIRE GUIDE
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6178393
• Report Number: 1820334-2016-01477
• Device Sequence Number: 16382666
• Product Code: DXQ
• UDI-Device Identifier: 00827002005112
• UDI-Public: (01)00827002005112(17)210930(10)7279411
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2017

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: TSCF-35-145-3
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/17/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/15/2016
• Supplement Report FDA Received Date: 06/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1