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

Model Number	G03540
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product code = dqx wire, guide, catheter.Occupation = non-healthcare professional.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 patient contact, a hair was found inside the package of a safe-t-j amplatz extra-stiff support wire guide.The device did not make contact with any patient.
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
Investigation evaluation: reviews of the complaint history, device history record, documentation, manufacturing instructions, and quality control procedures, as well as a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device revealed a black fiber of unknown source attached to the spiral holder of the device.No other defects were observed.Additionally, a document-based investigation evaluation was performed.The device was otherwise packaged 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.Reviews of the manufacturer¿s instructions and quality control procedures were conducted, and no gaps were discovered.Based on the information provided and the examination of the returned product, investigation has nonetheless concluded that the presence of the fiber can be related to the manufacturing and packaging of the device.Measures are being conducted to address this failure mode.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.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 AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8846222
• Report Number: 1820334-2019-01882
• Device Sequence Number: 11167304
• Product Code: DQX
• UDI-Device Identifier: 00827002035409
• UDI-Public: (01)00827002035409(17)220721(10)NS8017819
• Combination Product (Y/N): N
• 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): 07/31/2019

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: 07/21/2022
• Device Model Number: G03540
• Device Catalogue Number: THSCF-38-100-3-AES
• Device Lot Number: NS8017819
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2019
• Initial Date Received by Manufacturer: 07/25/2019
• Supplement Date Received by Manufacturer: 08/21/2019
• Initial Report FDA Received Date: 07/31/2019
• Supplement Report FDA Received Date: 08/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1