MAUDE Adverse Event Report: COOK INC APPROACH CTO MICROWIRE WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Model Number	G50790
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 that a piece of white thread was found inside the unopened approach cto microwire wire guide packaging.This event occurred prior to patient contact.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the complaint history, device history record, documentation, quality control, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed the presence of the reported foreign matter, which was present and readily observed.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, the examination of the returned product, and the results of our investigation, the root cause of the failure mode was related to the manufacturing and packaging of the device.We will continue to monitor for similar complaints.Per the quality engineering risk assessment, no further action is required.

• Brand Name: APPROACH CTO MICROWIRE WIRE GUIDE
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7426986
• Report Number: 1820334-2018-00792
• Device Sequence Number: 1191150
• Product Code: DQX
• UDI-Device Identifier: 00827002507906
• UDI-Public: (01)00827002507906(17)201107(10)6900920
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K081337
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2018

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 Model Number: G50790
• Device Catalogue Number: CMW-14-300-6G
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/19/2018
• Supplement Date Received by Manufacturer: 05/01/2018
• Initial Report FDA Received Date: 04/12/2018
• Supplement Report FDA Received Date: 05/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1