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

Model Number N/A

Device Problems Material Frayed (1262); Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/13/2019

Event Type  malfunction  

Manufacturer Narrative

Product code: dqx.Concomitant medical products: skater drainage catheter.Pma/510(k) #: preamendment.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported a safe-t-j fixed core wire guide was used to place another manufacturer's drain in the lower left quadrant of the patient's abdomen.After placement, the wire guide became stuck in the patient.As reported, the operator "had to remove the drain, retrieve the guide wire, then start over with the drain placement.When the drain was removed it was noted that the end was split.Ct scan was done to assure that nothing was left in the patient.Another drain was placed without incident." the wire guide was found frayed and kinked upon removal.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Manufacturer Narrative

B5: the access site was the left upper quadrant.It was previously only reported the device was placed in the lower left quadrant.D11: the catheter used in the procedure was determined to be a 5.0fr cook catheter during the investigation.It also should be noted the needle and dilators used during the procedure were cook inc products.D10: product received on: 25jul2019.Investigation/evaluation: a review of the complaint history, device history record, drawing, and quality control, as well as a visual inspection and dimensional verification, were conducted during the investigation.One damaged wire guide was returned inserted through a catheter.The distal end of the wire, exiting out of the catheter endhole, was elongated in 2 regions.No damage was observed on the wire guide exiting out the proximal end of the catheter.The wire guide could not be removed from the catheter due to excessive resistance.Dimensional analysis of the coiling of the wire confirmed that it was within the correct specifications and tolerances.The failure mode was determined to be caused by the unraveling of the wire guide, and was unrelated to the catheter.Additionally, a document based investigation evaluation was performed.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The device's design history files were reviewed.The risks associated with these devices are acceptable when weighed against the benefits.The device history record for the complaint lot revealed no related nonconformances.A database search revealed no other complaints have been reported for the complaint device lot.There is no evidence to suggest there is any nonconforming product in house or out in the field.Based on the information provided, the examination of returned product, and the results of the investigation, a definitive root cause could not be established.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.Cook will continue to monitor for similar complaints.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 Description

See h10.

• Brand Name: SAFE-T-J FIXED CORE WIRE GUIDE
• Type of Device: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8832357
• MDR Text Key: 175673185
• Report Number: 1820334-2019-01812
• Device Sequence Number: 1
• Product Code: DXQ
• UDI-Device Identifier: 00827002005297
• UDI-Public: (01)00827002005297(17)240419(10)9632252
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/19/2024
• Device Model Number: N/A
• Device Catalogue Number: TSCF-35-80-3
• Device Lot Number: 9632252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2019
• Date Manufacturer Received: 09/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10.; SEE H10.
• Patient Age: 27 YR
• Patient Weight: 105