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

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); No Code Available (3191)
Date of Event	06/30/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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
Customer reported that a patient was undergoing an unspecified procedure using a cope nitinol mandril wire guide.The wire broke off while in the pancreatic duct during the procedure.The actions taken by the clinical staff are not known.Additional information was requested; no additional information was received as of the date of this report.A follow-up report will be submitted upon receipt of additional information.
Event or Problem Description
Customer reported that a patient was undergoing an unspecified procedure using a cope nitinol mandril wire guide.The wire broke off while in the pancreatic duct during the procedure.The actions taken by the clinical staff are not known.Additional information was requested; no additional information was received as of the date of this report.A follow-up report will be submitted upon receipt of additional information.Additional information: the customer reported that the wire fractured while the operator was attempting to dilate the pancreatic duct ostium.Subsequently, a portion of the wire was removed endoscopically, a portion was removed percutaneously, and a small portion was retained.This retained portion was later removed during a previously scheduled second surgery (pancreaticojejunostomy).
Additional Manufacturer Narrative
Investigation - evaluation: a review of documentation, drawings, verification of dimensions, partial returned device, complaint history, device history record, manufacturing instructions, specification and quality control data was conducted during the investigation.The manufacturing documents in place at the time of manufacture were reviewed and it was found that the device aspect in question was visually inspected by quality control and no notable gaps in production or processing controls were noted.The risk specification for this product includes the failure mode, wire guide does not withstand forces during insertion, manipulation, or withdrawal, and identifies that multiple risk controls are in place to mitigate the risk of this type of failure.The device history records were reviewed.No related non-conformances were identified.A search of our complaint records indicates that this is the only complaint on the lot number and subassembly lot number.Two small portions of the wire were returned for investigation.During the investigation, it was found that the wire had three pieces break off.The first piece was unraveled round wire which can be seen in the attached image in the complaint.The second piece was a section of curled wire.The third piece of wire that had to be retrieved was not returned.The facility did not ship back the remaining guide wire that the three pieces broke off of.With the available information, the event may have been due to product use or handling related because the facility followed up with questions regarding wire separation and said the device was not kinked but resistance was encountered during removal.The risk analysis for this failure mode was reviewed and it was determined that no additional risk mitigating activity is required at this time.We will notify the appropriate personnel and continue to monitor for similar complaints.

• Brand Name: COPE NITINOL MANDRIL WIRE GUIDE
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6727908
• Report Number: 1820334-2017-01761
• Device Sequence Number: 762269
• Product Code: DXQ
• UDI-Device Identifier: 00827002084278
• UDI-Public: (01)00827002084278(17)210711(10)7074336
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/30/2017

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-18SP-60-COPE-NT
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/06/2017
• Supplement Date Received by Manufacturer: 07/17/2017; 10/12/2017
• Initial Report FDA Received Date: 07/20/2017
• Supplement Report FDA Received Date: 08/01/2017; 10/30/2017
• 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