MAUDE Adverse Event Report: COOK INC COPE STAINLESS STEEL MANDRIL WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/11/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age of patient at time of event is currently unknown as information was not provided.Sex of patient at time of event is currently unknown as information was not provided.(b)(4).The event is currently under investigation.
Event or Problem Description
During a pancreatic drainage intervention, the end of the guide broke inside the patient's pancreas upon withdrawal after passing through a fine needle.The guide piece remained in the patient.According to the physician, it was impossible to retrieve given its location.According to the initial reporter, no procedures have been planned to remove the separated portion at this time.Additional information has been requested.However, it was not provided at the time of this report.
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation.A review of complaint history, drawing, quality control and specifications was conducted during the investigation.The device was not returned to assist in the investigation.Based on the description of the event and the fact that there was no obvious defect regarding the manufacturing of the wire guide, it is possible that the wire guide tip caught on the introducing needle and force beyond design requirements was used to remove the guide.Affixed to the wire guide protective shipping tube is a caution label that pictorially cautions against the reverse process of withdrawing the wire guide in the needle as damage may occur.The manipulation of the wire through the needle may cause damage to the coil.Less frequently, patient anatomy makes withdrawal of the wire guide difficult resulting in damage when the force exceeds design specification.Based on the information provided and the results of our investigation, a definitive root cause could not be determined.There are adequate controls in place to ensure the product is manufactured as intended.There is no evidence to suggest the product was not manufactured to current specifications.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.Per the quality engineering risk assessment (qera) no further action is required.
Event or Problem Description
During a pancreatic drainage intervention, the end of the guide broke inside the patient's pancreas upon withdrawal after passing through a fine needle.The guide piece remained in the patient.According to the physician, it was impossible to retrieve given its location.According to the initial reporter, no procedures have been planned to remove the separated portion at this time.Additional information has been requested.However, it was not provided at the time of this report.

• Brand Name: COPE STAINLESS STEEL MANDRIL WIRE GUIDE
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5498441
• Report Number: 1820334-2016-00159
• Device Sequence Number: 18957356
• Product Code: DXQ
• UDI-Device Identifier: 00827002051775
• UDI-Public: (01)00827002051775(17)201115(10)6327491
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2016

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: PMG-18-60-COPE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/11/2016
• Device Age: 4 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/25/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/14/2016
• Supplement Report FDA Received Date: 06/16/2016
• 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: Other