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

Model Number	G00507
Medical Device Problem Codes	Stretched (1601); Unraveled Material (1664); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer name and address= (b)(6).Pma/510(k) number = k171764.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
As reported, during a procedure involving placement of an abdominal drain, a safe-t-j fixed core wire guide unraveled.The wire was not altered prior to use.Resistance was not encountered upon insertion of the wire.After the unspecified cook 8.5 drain was placed, the user attempted to remove the wire from the drain; however, the wire was stuck and it unraveled upon removal.Another drain was inserted.A section of the device did not remain inside the patient¿s body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported, during a procedure involving placement of an abdominal drain, a safe-t-j fixed core wire guide unraveled.The wire was not altered prior to use.Resistance was not encountered upon insertion of the wire.After the unspecified cook 8.5 drain was placed, the user attempted to remove the wire from the drain; however, the wire was stuck, and it unraveled upon removal.Another drain was inserted.A section of the device did not remain inside the patient¿s body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Upon return and initial evaluation of the device, the wire was unraveled, and the safety wire and mandril protruded and were exposed.The wire was stretched and elongated.Investigation evaluation: reviews of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, and quality control procedures were conducted during the investigation.A visual inspection of the complaint device was also conducted.The complaint device was returned to cook for investigation.The distal end of the wire was unraveled, stretched, and elongated; however, the weld ball was intact.The mandril and safety wire were exposed, protruding from the device.A document-based investigation evaluation was performed.There have been no other reported complaints for this lot number.Two relevant non-conformances were noted on the lot; however, all affected product was scrapped and not replaced.The product ifu states "do not advance or withdraw a wire guide when resistance is encountered, as a perforation could occur.¿ the information provided upon review of the dmr, dhr, ifu, and investigation of the returned device suggests that there is evidence the device was manufactured to specification.Although two relevant non-conformances were noted on the lot, all non-conforming product was scrapped, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot-related complaints have been received from the field.Therefore, it was concluded that there is no evidence that additional non-conforming product exists in house or in the field.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Based on the information provided and the results of the investigation, cook has concluded that unintended user error contributed to this event, as the wire was reportedly stuck in the drain and began to unravel upon removal.The ifu cautions the user not to withdraw the wire if resistance is encountered.The risk analysis for this failure mode was reviewed and no additional escalation was required.The appropriate personnel have been notified and cook will continue to monitor for similar events.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.H3: device evaluated by mfg = other (81) - device evaluation has begun; however, a conclusion is not yet available.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
Upon return and initial evaluation of the device, the wire was unraveled, and the safety wire and mandril protruded and were exposed.The wire was stretched and elongated.

• 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
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 17128501
• Report Number: 1820334-2023-00759
• Device Sequence Number: 6400133
• Product Code: DQX
• UDI-Device Identifier: 00827002005075
• UDI-Public: (01)00827002005075(17)251230(10)13603263
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/27/2023

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: 12/30/2025
• Device Model Number: G00507
• Device Catalogue Number: TSCF-35-145-1.5
• Device Lot Number: 13603263
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/31/2023
• Supplement Date Received by Manufacturer: 07/18/2023; 08/31/2023
• Initial Report FDA Received Date: 06/14/2023
• Supplement Report FDA Received Date: 08/03/2023; 09/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/30/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male