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	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/13/2017
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 a drainage procedure using a safe-t-j fixed core wire guide.The guide wire broke within the abdominal wall during placement.A physician consult determined that there is no need for surgical intervention due to the size and location of the fragment; the fragment remains retained within the abdominal wall.No further patient or event information is available.A portion of the broken device is available for evaluation; however the device has not been received by the manufacturer as of the date of this report.
Additional Manufacturer Narrative
Corrected data: common name: wire, guide, catheter, product code: dqx, preamendment.Investigation - evaluation: a review of dimensional verification, complaint history, device history record, documentation, drawing, manufacturing instructions, visual inspection, specifications, and quality control data was conducted during the investigation.Visual inspection of the returned device was performed.One tscf-35-80-3, was returned in the used and damaged condition with the distal weld absent from the mandrel and coil.There are two large radii bends; it is unknown whether the bends were created by the physician intentionally to facilitate the procedure, were a result of the patient anatomy, or were introduced after the procedure due to shipping and handling without any protective holder.These bends are located 13.5 cm and 21.5 cm from the proximal end of the wire.The distal end of the wire is damaged such that the distal weld is missing, and the coil has separated from the distal portion of the mandrel and is partially unraveled.A portion of the coil appears to be missing, although it is difficult to confirm dimensions based on the unraveled condition.The mandrel core is protruding and is curved in multiple planes like a helix.The intact portion of the coil was elongated, and we are unable to determine the length of the missing portion of the coil, although it does not appear to be completely intact on the returned device.No dimensions were found to be out of specification.The device history record was reviewed for lot#7766379, and two non-conformances were recorded within the manufacturing department.These nonconformances were recorded for "pulled out while gaging" and "loose dirt".The two items that pulled out while gaging were scrapped (discarded), and the four devices containing loose foreign matter were reworked and verified prior to additional processing.To date, a further search of our trackwise records revealed this complaint to be the only reported complaint associated to the complaint lot number (7766379).Based on current information and further review of this complaint, it is feasible to suggest that "off label" use of the tscf-35-80-3 was the cause of this event.Per the quality engineering risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.The appropriate personnel have been notified, and we will continue to monitor 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: 6686547
• Report Number: 1820334-2017-01620
• Device Sequence Number: 1735747
• Product Code: LJS
• UDI-Device Identifier: 00827002005297
• UDI-Public: (01)00827002005297(17)220413(10)7766379
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K133634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2018

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: TSCF-35-80-3
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/14/2017
• Supplement Date Received by Manufacturer: 12/19/2017
• Initial Report FDA Received Date: 07/05/2017
• Supplement Report FDA Received Date: 01/11/2018
• 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
• Patient Age: 65 DA