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

Model Number	N/A
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: purchasing.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 or Problem Description
It was reported a safe-t-j fixed core wire guide was to be used in an unknown patient for an unknown procedure.As reported, "while prepping for an unknown procedure it was noted prior to opening the sealed package of the safe-t-j fixed core wire guide.That there was a hair-like fiber inside of the sealed package.The package was not opened." the device did not make patient contact.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged or unavailable.D10 ¿ product received on: 07may2019.Investigation ¿ evaluation: a review of the complaint history, device history record, and quality control of the device, as well as a visual inspection, were conducted during the investigation.The visual inspection of the complaint device showed the device remained sealed within the original packaging, all sides of the packaging were sealed, and no damage was observed.A light brown filament was observed, sealed, in the lower right corner of the package.The device was confirmed to be nonconforming.Additionally, a document based investigation evaluation was performed.Sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the device history record for lot 5007918 revealed no nonconformances.A software search revealed no other complaints have been reported for the complaint device lot.As there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.Based on the information provided, inspection of returned product, and the results of the investigation, the failure mode was determined to be manufacturing related.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 includes information known at this time.A follow up report will be submitted should additional relevant information become available.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 WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8590891
• Report Number: 1820334-2019-01106
• Device Sequence Number: 2075013
• Product Code: DXQ
• UDI-Device Identifier: 00827002005242
• UDI-Public: (01)00827002005242(17)190601(10)5007918
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2019

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: 06/01/2019
• Device Model Number: N/A
• Device Catalogue Number: TSCF-35-50-3
• Device Lot Number: 5007918
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2019
• Initial Date Received by Manufacturer: 05/03/2019
• Supplement Date Received by Manufacturer: 05/24/2019
• Initial Report FDA Received Date: 05/08/2019
• Supplement Report FDA Received Date: 05/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1