MAUDE Adverse Event Report: COOK INC FLEXOR RAABE GUIDING SHEATH; DYB INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/02/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
The nurse opened the flexor raabe guiding sheath for use during vascular surgery and discovered that it was unable to be used due to a cracked valve.Therefore, the device did not make contact with the patient.The patient did not experience any adverse effect due to this occurrence.
Additional Manufacturer Narrative
Evaluation- a review of the complaint history, device history record, documentation, quality control, and specifications and a visual inspection of an image provided were conducted.The device was not return for evaluation; however, a photo was provided that confirmed the sealed package contained a valve with cracked check-flo disc fitting it was reported that the failure was discovered prior to patient contact.The device history record was reviewed and noted 0 non-conformances.The check flo valve assembly is fully inspected per quality control for any non-conformance.There is no evidence to suggest that product was not manufactured to current specifications.There is no evidence to suggest all items in the lot or similar devices in the field are nonconforming or defective.Without visual, dimensional, and/or functional testing of the product, we are unable to determine if this is a manufacturing issue.Based upon the information provided and the characteristics displayed, it is plausible to suggest that this incident was shipping related, handling related or storage related.We will continue to monitor for similar events.

• Brand Name: FLEXOR RAABE GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6413083
• Report Number: 1820334-2017-00385
• Device Sequence Number: 925804
• Product Code: DYB
• UDI-Device Identifier: 00827002116337
• UDI-Public: (01)00827002116337(17)171020(10)5375949
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2017

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-7.0-38-55-RB-RAABE
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/15/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/17/2017
• Supplement Report FDA Received Date: 04/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR