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

Model Number	N/A
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation ¿ evaluation a review of the device history record, documentation, drawing, manufacturing instructions, quality control, specifications, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that there was teflon delaminating from the wire in at least 3 different regions.When the inserter was used to straighten the wire, it was observed that the teflon was very friable.The wire guide extended 13 cm outside of the protective holder, rather than the specified 7 cm.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 indicated that the lot met all finished goods release criteria.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 complaint is confirmed.However, a definitive root cause could not be determined.The most likely cause of this event is damage in shipping, damage in storage, or damage upon removal from the package.We will continue to monitor for similar complaints.Per the risk assessment, no further action is required.
Event or Problem Description
The international customer reported that, when the operator went to use the amplatz extra stiff support wire guide, it was observed that the outer coating at the j end of the device was damaged.The nature of the damage was not elaborated upon by the customer.The device was reportedly not used in the patient.When the device was returned and evaluated, this damage was confirmed to specifically be a flaking of the coating.The investigation of the device is complete as of (b)(6) 2018.
Additional Manufacturer Narrative
Correction: manufacturer report # from 1820334-0218-00390 to 1820334-2018-00390.

• Brand Name: 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: 7298198
• Report Number: 1820334-2018-00390
• Device Sequence Number: 19105219
• Product Code: DXQ
• UDI-Device Identifier: 00827002042377
• UDI-Public: (01)00827002042377(17)220623(10)7920413
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2018

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: N/A
• Device Catalogue Number: THSCF-35-80-3-AES
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/05/2018
• Supplement Date Received by Manufacturer: 02/26/2018
• Initial Report FDA Received Date: 02/26/2018
• Supplement Report FDA Received Date: 02/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1