MAUDE Adverse Event Report: COOK INC AMPLATZ STIFF SUPPORT WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Model Number	G27035
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product code = dqx.Occupation = non-healthcare professional.Pma/510(k) number = preamendment.Usage of device = device not used.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 "burr" was observed on the tip of the amplatz stiff support wire guide.This could be seen thru the tyvek pouch, and was noticed in the inventory room of the facility by the customer.The package was not opened.
Additional Manufacturer Narrative
A review of the manufacturing instructions, drawing, quality control, complaint history, device history, documentation, inspection of unused product, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed the reported burr on the device, seen through the tyvek packaging.This was confirmed to be peeling of the device¿s coating.Additionally, a document-based investigation evaluation was performed.There is evidence to suggest the product was not made to specifications.A review of the device history record showed one nonconforming event which could contribute to this failure mode; however, the affected units were scrapped and not replaced.It should be noted there were no other reported complaints for this lot number.Furthermore, a review of the manufactures instructions and quality control procedures was conducted, and no gaps were discovered.Based on the information provided, the examination of the returned product, and the results of our investigation, the reported failure mode was traced to manufacturing.Retraining has been issued to affected departments.Cook 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.
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: AMPLATZ 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: 8264153
• Report Number: 1820334-2019-00150
• Device Sequence Number: 16658225
• Product Code: DQX
• UDI-Device Identifier: 00827002270350
• UDI-Public: (01)00827002270350(17)210909(10)7228602
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 04/01/2019

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: No Information
• Device Expiration Date: 09/09/2021
• Device Model Number: G27035
• Device Catalogue Number: THSF-35-260-ASG
• Device Lot Number: 7228602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2019
• Initial Date Received by Manufacturer: 01/10/2019
• Supplement Date Received by Manufacturer: 03/29/2019
• Initial Report FDA Received Date: 01/21/2019
• Supplement Report FDA Received Date: 04/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1