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 Codes	Device Embedded In Tissue or Plaque (3165); No Code Available (3191)
Date of Event	08/01/2017
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
International customer reported that a patient was undergoing placement of a catheter for an abscess drainage.A cope stainless steel mandril wire guide was utilized for the catheter placement.The customer stated that a portion of the wire "came away and was still inside the patient" when the device was being removed.The physician used a snare kit to safely remove the retained piece of wire from the implant site.The patient is reported as "fine." the device is not available for evaluation.
Additional Manufacturer Narrative
Corrected data: product code: dqx.Investigation - evaluation: a review of device history record, documentation, quality control documents, manufacturing instructions, complaint history, and specifications was conducted during the investigation.The complaint device was not returned; therefore, device failure analysis and physical examination of the device used in this case could not be performed.The wire guide is manufactured according to specification detailing and verifying the geometry of the wire guide.After assembly of the product, it is independently inspected, including 100% verification for dimensional and visual criteria as part of quality control procedures.In summary, there are adequate controls in place to ensure the product is manufactured as intended.The device history record for lot number 7425022 was reviewed and no related non-conformances were identified.A search of our complaint records indicates that this is the only complaint on the lot number at the time of investigation.It is possible that the wire guide was met with forces beyond its intended use or encountered a tortuous patient anatomy, leading to the failure described.It is also possible that the wire guide was withdrawn through a needle which could have led to the device sheering off in the patient.However, without visual, dimensional, or functional testing of the involved components, a definitive root cause could not be determined.A quality engineering risk assessment was performed to address this failure mode.No further action is required.We will notify the appropriate personnel and 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: 6777279
• Report Number: 1820334-2017-02194
• Device Sequence Number: 221012
• Product Code: DXQ
• UDI-Device Identifier: 00827002051775
• UDI-Public: (01)00827002051775(17)211130(10)7425022
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2017

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-18-60-COPE
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/01/2017
• Supplement Date Received by Manufacturer: 11/08/2017
• Initial Report FDA Received Date: 08/09/2017
• Supplement Report FDA Received Date: 11/28/2017
• 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