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

Model Number	N/A
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
The international customer reported that a hair was present in the packaging of the amplatz extra stiff support wire guide.The customer confirmed that no patient injury occurred.It is unknown when the hair was discovered, and if the product was opened and used.No further information was made available.The device is reportedly available for return; however, as of the date of this report, no product has yet been received for evaluation.
Additional Manufacturer Narrative
Product code: dqx.The product was unopened and unused at the time of the event.The device did not come into contact with a patient.Investigation - evaluation: a review of the complaint history, device history record, documentation, specifications, quality control, and visual inspection of the returned device was conducted during the investigation.One amplatz extra stiff support wire guide was returned in an unopened, sterile condition.Visual examination identified a single strand of foreign matter from unidentifiable source, black in color, measuring in its current state at approximately 1.3 centimeters (cm) within the sealed package.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that could contribute to this failure mode.A complaint history search revealed that there were no other reported complaints for this lot number.Per manufacturing quality control documentation, "inspect all package seals (end seals, side seals and chevron seal if applicable).Examine each seal for defects, foreign matter.Product must be free of any visible cuts, holes or foreign matter." based on the information provided, examination of the returned product, and the results of our investigation, the root cause for the foreign matter was determined to be related to the manufacturing process.Per the quality engineering risk assessment, no further action is required.Monitoring will continue to be performed for similar complaints.

• 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: 6914608
• Report Number: 1820334-2017-03430
• Device Sequence Number: 16258753
• Product Code: DXQ
• UDI-Device Identifier: 00827002042377
• UDI-Public: (01)00827002042377(17)220817(10)8087804
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 01/17/2018

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: 09/20/2017
• Supplement Date Received by Manufacturer: 01/12/2018
• Initial Report FDA Received Date: 10/04/2017
• Supplement Report FDA Received Date: 01/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1