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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/16/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This mdr is being submitted past the 30 day reporting requirement as part of a retrospective review of the report.A retrospective review of the complaint record determined that this report should have been submitted as a malfunction report.In this case, no patient injury occurred; however, this may be likely to cause or contribute to a serious injury if it recurred.The preliminary investigation results have been sent today.We will update later if any further information is determined.Investigation - evaluation a review of the complaint history, specifications, trends, quality control, and visual inspection of the returned device was conducted during the investigation.One sheath was returned with the check flo assemble detached.The sheath and check flo assembly were not damaged.The flexor sheath inner and outer diameters were measured.The tubing was found to be the correct size and type per the relevant drawing.Measurements of the check flo assembly confirmed the correct assembly was used during manufacturing.Inspection of the flare found it to be the correct size and shape.Per the quality engineering risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.At this time, a definitive root cause cannot be determined.Additional investigation is pending.
Event or Problem Description
The customer reported that prior to use, the body shaft was found separated from the valve.
Additional Manufacturer Narrative
Investigation - evaluation a review of the complaint history, specifications, trends, quality control, and visual inspection of the returned device was conducted during the investigation.One sheath was returned with the check flo assembly detached.The sheath and check flo assembly were not damaged.The flexor sheath inner and outer diameters were measured and the tubing was found to be the correct size and type.Measurements of the check flo assembly confirmed the correct assembly was used during manufacturing.Inspection of the flare found the flare to be the correct size and shape.A document-based investigation evaluation was also performed.There is no evidence to suggest the product was not made to specifications.Based on the information provided and results of the investigation the most likely root cause cannot conclusively be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• 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: 6530462
• Report Number: 1820334-2017-00941
• Device Sequence Number: 16228174
• Product Code: DYB
• UDI-Device Identifier: 00827002481879
• UDI-Public: (01)00827002481879(17)170806(10)5189916
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2017

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-4.0-35-55-RB-RAABE
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/16/2015
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/28/2017
• Supplement Report FDA Received Date: 06/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1