MAUDE Adverse Event Report: COOK INC SAFE-T-J NEPHROSTOMY DRAINAGE SET FIXED CORE WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Catalog Number	TSCF-38-80-3-PNS
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) #: pre-amendment (b)(4).Investigation - evaluation: a review of the complaint history, device history record, quality control, specifications, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that the safety wire broke from the distal weld, resulting in elongation of the coil in several areas in the distal portion of the guide.The weld connection was still present and connected to the coil confirming no portion of the guide remained in the patient.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed 1 nonconformance where 2 devices were scrapped for broken safety wire.This nonconformance is similar to the failure mode of the complaint device, but it is not related since these devices were scrapped during qc.It should be noted there were no other reported complaints for this lot number.It is unclear what caused the wire guide to separate.There are no additional details about the nephrostomy tube, but considering that the procedure was meant to replace the tube it is possible that the tube contained a tortuous path that caused the wire guide to elongate as it was being advanced and as the tube was being retrieved over the wire guide.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.The appropriate personnel have been notified.We will continue to monitor for similar complaints.Per the quality engineering risk assessment, no further action is required.
Event or Problem Description
An international customer reported that a safe-t-j nephrostomy drainage set fixed core wire guide was used to exchange a nephrostomy tube.The wire guide had difficulty advancing through the tube and straightening at the end.A radiologist assisted in feeding the guide wire through the tube and observed the guide wire to be "floppy" and the outer/covering sheath had come away when exchanging the old tube over the guide wire.A new nephrostomy tube was exchanged over the guide wire and the guide wire was removed.The procedure was completed as intended.Device evaluation identified elongation of the guide wire.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.  according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: SAFE-T-J NEPHROSTOMY DRAINAGE SET 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: 7764696
• Report Number: 1820334-2018-02269
• Device Sequence Number: 1319455
• Product Code: DXQ
• UDI-Device Identifier: 00827002020085
• UDI-Public: (01)00827002020085(17)221023(10)8256062
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/08/2018

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 Expiration Date: 10/23/2022
• Device Catalogue Number: TSCF-38-80-3-PNS
• Device Lot Number: 8256062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2018
• Initial Report FDA Received Date: 08/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR