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

Model Number	G00507
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product code = dqx.Pma/510(k) number = pre-amendment.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
It was reported, during an unspecified procedure, the tip of the safe-t-j fixed core wire guide frayed.According to the initial reporter, as the wire was being inserted into the catheter, "the physician felt strange" and decided to remove the wire guide.Upon removal, he noticed the tip of the device had frayed.Another product was used to complete the procedure.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Event or Problem Description
Additional information received 05dec2019.As reported, the device was used with a cook ult 7.0 catheter.The procedure performed was a percutaneous transhepatic cholangiography drainage.The patient did not have any noted vessel tortuosity or calcification.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.On return of device (b)(6) 2019, a gap/space was observed between the coils at the j-curve of the device.No other damage was noted to the device.There is no evidence to suggest that the observed device failure would be likely to cause or contribute to a death or a serious injury if the failure were to recur.Furthermore, there is no evidence that the device caused or contributed to a serious injury, as no life-threatening or permanently impairing injury took place, nor was intervention taken as a result of the device failure which would be required to prevent permanent impairment or damage to the patient.As such, the event is not reportable under fda 21 cfr part 803 as it does not meet the criteria for a death, serious injury and/or product malfunction.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: SAFE-T-J FIXED CORE WIRE GUIDE
• Common Device Name: DQX
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9346902
• Report Number: 1820334-2019-02923
• Device Sequence Number: 3229475
• Product Code: DQX
• UDI-Device Identifier: 00827002005075
• UDI-Public: (01)00827002005075(17)240710(10)9811074
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2019

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: 07/10/2024
• Device Model Number: G00507
• Device Catalogue Number: TSCF-35-145-1.5
• Device Lot Number: 9811074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2019
• Supplement Date Received by Manufacturer: 11/25/2019
• Initial Report FDA Received Date: 11/20/2019
• Supplement Report FDA Received Date: 12/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1