MAUDE Adverse Event Report: COOK INC SAFE-T-J AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Model Number G03565

Device Problems Flaked (1246); Contamination /Decontamination Problem (2895)

Patient Problem No Patient Involvement (2645)

Event Date 08/25/2020

Event Type  malfunction  

Manufacturer Narrative

Common name & product code = dqx wire, guide, catheter customer name and address= (b)(6).Ma/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 Description

As reported, during an unknown procedure, foreign matter was found on the tip of a safe-t-j amplatz extra-stiff support wire guide.This was observed upon opening the package of the device.The device did not make contact with the patient.Another device of the same type was used to complete the procedure.

Manufacturer Narrative

Summary of event: as reported, during an unknown procedure, foreign matter was found on the tip of a safe-t-j amplatz extra-stiff support wire guide.This was observed upon opening the package of the device.The device did not make contact with the patient.Another device of the same type was used to complete the procedure.Upon evaluation of the complaint device on 17nov2020, foreign matter was not found; however, the coating was noted to have flaked from the device.Investigation evaluation: reviews of the complaint history, device history record, drawing, documentation, manufacturing instructions, quality control, and specifications were conducted during the investigation.A visual inspection of the complaint device was also conducted.The complaint device was returned to cook for investigation.Examination noted a green material on the wire tip near the distal weld.Upon further investigation, the green material appears to be the coating that flaked off the device.A document-based investigation evaluation was performed.No related non-conformances were found, and there have been no other reported complaints for this lot number.The information provided upon review of complaint file, device history record, complaint history, device master record, and design verification testing provide objective evidence to support that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot 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 a definitive conclusion could not be determined.As the device package was opened, it is unknown where and when the tfe coating flaked from the device.There are multiple visual inspections of the wire during manufacturing and quality control, including 100% inspection to verify that the tfe is not flaking or peeling.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.

Event Description

Upon evaluation of the complaint device on 17nov2020, foreign matter was not found; however, the coating was noted to have flaked from the device.

• Brand Name: SAFE-T-J AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE
• Type of Device: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10474177
• MDR Text Key: 209615319
• Report Number: 1820334-2020-01595
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 00827002035652
• UDI-Public: (01)00827002035652(17)250422(10)13104765
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 12/14/2020

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
• Device Operator: Health Professional
• Device Model Number: G03565
• Device Catalogue Number: THSCF-35-180-3-AES
• Device Lot Number: 13104765
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2020
• Initial Date Manufacturer Received: 08/27/2020
• Initial Date FDA Received: 08/31/2020
• Supplement Dates Manufacturer Received: 11/17/2020
• Supplement Dates FDA Received: 12/14/2020
• Patient Sequence Number: 1