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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/24/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product code: dqx.(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
The international customer reported that, during an abdominal (median) approach of the intrahepatic bile duct with a cope stainless steel mandril wire guide, the wire guide fractured.The fracture was discovered upon the removal of the wire guide following catheter placement.The operator of the device believed that the retrieval of the portion of wire that fractured off would be difficult, and as a result the fragment was left in the patient.No adverse patient effects have been reported as a result of the portion of the wire which was left in the patient.The circumstances surrounding the handling and usage of the device are not known.The product is reportedly available for return; however, as of the date of this report, no device has yet been received.
Additional Manufacturer Narrative
Corrected information: device evaluated by mfr.Investigation summary: a review of the dimensional verification, complaint history, documentation, device history record, specifications, quality control, manufacturing investigation and a visual inspection of the returned device were conducted during the investigation.One wire guide was returned in an open and used condition with biomatter present.Solder appears to be intact.No weld present at the distal tip of the coil.There are two kinks present along length of the wire at approximately 120 mm from proximal end and 720 mm from proximal end.The entire length of the mandril from proximal end to distal tip is measured to be approximately 79.4 cm.The length specification for this wire guide is 80 cm with a tolerance of +/- 4 cm and, therefore, the length is in specification.Several ct images were included showing the separated tip segment of the wire guide remaining inside the patient.Additionally, a document based investigation evaluation was performed.There was no evidence to suggest the product was not made to specifications.A review of the device history record found no other non-conformances associated with the complaint device lot number.It should be noted there were no other reported complaints for this lot number.There is no evidence to suggest all items in the lot or similar devices in house are nonconforming/defective.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.However, appropriate measures have been initiated to address this failure mode.The quality engineering risk assessment for this failure mode was reviewed and it was determined that no additional risk mitigating activity is required at this time.The appropriate personnel will be notified and we will continue to monitor for similar complaints.

• 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: 6848676
• Report Number: 1820334-2017-02798
• Device Sequence Number: 1430253
• Product Code: DQX
• UDI-Device Identifier: 00827002051768
• UDI-Public: (01)00827002051768(17)220207(10)7608818
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: PMG-18-80-COPE
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/25/2017
• Supplement Date Received by Manufacturer: 11/21/2017
• Initial Report FDA Received Date: 09/07/2017
• Supplement Report FDA Received Date: 12/06/2017
• 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