MAUDE Adverse Event Report: COOK INC FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH; DYB INTRODUCER, 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	09/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.
Event or Problem Description
It was reported, upon opening a flexor high-flex ansel guiding sheath a hair was observed in the packaging.There was no patient involvement.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the device history record, quality control, and visual inspection of the returned device was conducted during the investigation.A visual examination of the sealed outer package image shows that the package contained free floating foreign matter (most likely a hair strand) from an unknown source.A document-based investigation was performed.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.Based on the information provided, examination of the returned product, and the results of our investigation; the root cause was determined to be related to manufacturing.Per the quality engineering risk assessment, no further action is required.Appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.

• Brand Name: FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6852780
• Report Number: 1820334-2017-02908
• Device Sequence Number: 1196470
• Product Code: DYB
• UDI-Device Identifier: 00827002477001
• UDI-Public: (01)00827002477001(17)191129(10)7474484
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• 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): 12/06/2017

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: KCFW-10.0-35-45-RB-HFANL1-HC
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/07/2017
• Supplement Date Received by Manufacturer: 12/05/2017
• Initial Report FDA Received Date: 09/08/2017
• Supplement Report FDA Received Date: 12/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR