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	Unraveled Material (1664)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The 510k status: preamendment.(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
The customer reported that, during a deep pelvic abscess drainage procedure, the safe-t-j fixed core wire guide got caught inside the metal stiffener when the catheter was introduced over the wire.The user managed to pull the wire out eventually, but reported that the wire had begun to unravel.A post-procedure computed tomography scan confirmed that no pieces of the wire guide were left in the patient - the wire was removed in its entirety.The operator of the device stated that there may have been too much wire in the abscess, which caused the wire to kink when the metal stiffener was introduced.The amount of wire that had been looped in the abscess was not readily observable, because this procedure was done under ultrasound guidance, rather than fluoroscopy.The abscess was reportedly deep in the patient's pelvis, and was only about 5-7 cm in diameter.The wire is reportedly available for return; however, as of the date of this report, no device has yet been received for evaluation.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control data, dimensional verification and visual inspection was conducted during the investigation.Evaluation of the returned device was performed.The wire guide begins to unravel approximately 75cm from the proximal end.No distal weld is present.The proximal weld is present and intact.The wire is severely kinked and flaking of the tfe coating present in multiple locations along the length of the wire.The distal ends of both the safety wire and mandril are exposed.Both the od of the wire guide and the id of the metal stiffener were measured to be in specification using calipers.The ifu for the catheter states, "under fluoroscopic control, perform standard techniques for placement of percutaneous drainage catheters, either by seldinger access or trocar access" and "once catheter is in desired location, remove any wire guides, trocars, or stiffeners, allowing the catheter to form its configuration." using ultrasound is a departure from the ifu which instructs to use fluoroscopy.The ifu warns "when inserting a stiffening cannula into a catheter with retention suture, hold suture during cannula insertion to avoid bunching or tangling of suture." the doctor stated that "wire guide got caught inside the metal stiffener when placing the catheter over the wire".The physician stated that, " he may have put too much of the wire guide into the abscess causing the guide to kink".The force that was used to attempt to untangle the components caused the suture to break and probably the wire guide to unravel from lack of clearance inside the cannula.A document-based investigation evaluation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.The dhr was reviewed and no non-conformances were noted for lot 8277025.Additionally, a search of the manufacturer's complaint database notes that this is the only complaint related to lot 8277025.Based on the provided information and visual inspection of the returned device, the root cause is determined to be product use or handling related; user technique.Per the quality engineering risk assessment no further action is required.We will continue to monitor for similar complaints and have notified the appropriate personnel of this event.

• 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: 7222787
• Report Number: 1820334-2018-00155
• Device Sequence Number: 2248262
• Product Code: DXQ
• UDI-Device Identifier: 00827002005525
• UDI-Public: (01)00827002005525(17)221110(10)8277025
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: TSCF-38-80-3
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/08/2018
• Supplement Date Received by Manufacturer: 02/27/2018
• Initial Report FDA Received Date: 01/26/2018
• Supplement Report FDA Received Date: 03/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DAWSON MUELLER DRAINAGE CATHETER; JCD10.0-38-20:STANDARD DILATOR