MAUDE Adverse Event Report: COOK INC BENTSON STRAIGHT FIXED CORE WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Model Number	G00691
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per the medwatch 3500a form, the device will not be returned.Per communication with the customer, the device was returned.Cook has not received any device related to this complaint.Common name & product code = dqx wire, guide, catheter.Complaint was received via medwatch 3500a form; however, per the reporter, the event was not reported to the fda.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
As reported, prior to an unknown procedure, a bentson straight fixed core wire guide was noted to be frayed.A physician reportedly noticed the wire was "floppy" and the wire core appeared to be frayed and damaged upon removal from a sterile bowl.The wire was replaced in the original packaging and was not used.The device did not make contact with the patient.
Additional Manufacturer Narrative
Event summary: as reported, prior to an unknown procedure, a bentson straight fixed core wire guide was noted to be frayed.A physician reportedly noticed the wire was "floppy" and the wire core appeared to be frayed and damaged upon removal from a sterile bowl.The wire was replaced in the original packaging and was not used.The device did not make contact with the patient.Investigation - evaluation.Reviews of the complaint history, device history record, documentation, manufacturing instructions, and quality control procedures of the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.A document-based investigation evaluation was thus conducted.A review of the device history record showed no nonconforming events which could contribute to this failure mode.A review of complaint history showed no additional complaints for this lot.Reviews of the manufacturing instructions and quality control procedures were also conducted, and no gaps were discovered.The available information provides objective evidence to support that the device was manufactured to specification.Based on the information provided, investigation has concluded that a cause for the device failure could not be established.Possible reasons for the failure may include shipping and/or user handling of the device.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment, no further action is required.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
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: BENTSON STRAIGHT 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: 9310881
• Report Number: 1820334-2019-02842
• Device Sequence Number: 438612
• Product Code: DQX
• UDI-Device Identifier: 00827002006911
• UDI-Public: (01)00827002006911(17)230117(10)8452815
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/17/2023
• Device Model Number: G00691
• Device Catalogue Number: TSFB-35-145
• Device Lot Number: 8452815
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/04/2019
• Supplement Date Received by Manufacturer: 04/03/2020
• Initial Report FDA Received Date: 11/12/2019
• Supplement Report FDA Received Date: 04/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1