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

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/12/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device evaluated by manufacturer.Actual device evaluated, visual inspection, quality control review.The preliminary investigation results have been sent today.We will update later if any further information is determined.This event is currently under investigation.
Event or Problem Description
It was reported that during an unspecified procedure using a flexor shuttle tibial guiding sheath, the junction fractured when the end user screwed the side-arm valve of the sheath to the check-flo valve.At the time of this report, patient outcome is unknown.
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 flexor shuttle tibial guiding sheath was returned for evaluation.Visual inspection of the device revealed the hub was separated from the flexor sheath.The flare of the flexor was noted to be of adequate size, though slightly deformed.This is indication that the flare was securely seated between the cap and adaptor.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 the results of the investigation it is feasible to suggest the device met resistance beyond its intended design.The most likely root cause of the reported failure may be related to user technique.Based on the information provided and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• Brand Name: FLEXOR SHUTTLE TIBIAL GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6531211
• Report Number: 1820334-2017-00940
• Device Sequence Number: 16353833
• Product Code: DYB
• UDI-Device Identifier: 00827002128361
• UDI-Public: (01)00827002128361(17)160101(10)3986805
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2017

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: KSAW-8.0-38-90-RB-SHTL-HC
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/12/2015
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/28/2017
• Supplement Report FDA Received Date: 06/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1