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

Catalog Number	KCFW-5.0-38-90-RB-RAABE
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This event is currently under investigation.A supplemental report will be provided upon conclusion.
Event or Problem Description
It has been reported that a flexor raabe guiding sheath device separated upon removal during an angiogram procedure.The device was placed in the patient's "leg" and was being used via contralateral approach.Although another manufacturer's wire guide was inside the sheath, it was said that the physician was withdrawing the sheath from the patient without having the dilator placed when the separation occurred.The patient was reported to have normal body habitus.No unintended section of the device remain inside the patient's body.The patient did not require any additional procedures due to this occurrence, nor have any adverse events been reported regarding the patient.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, drawings, dimensional verification, device history record, documentation, instructions for use (ifu), manufacturing instructions, specifications, quality control, and visual inspection of the returned device was conducted during the investigation.One used flexor raabe guiding sheath with check-flo valve and one wire guide were returned for evaluation.The outer nylon tubing was separated into two pieces and is only connected by the inner coiling wire.The distal end of the sheath appears to have accordion-like damage.Dimensional inspection did not reveal any evidence that the device was manufactured out of specifications.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Numerous design verification and validation activities have been performed to ensure that this device meets design requirements.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 the ifu, "sheath removal: insert wire guide at least 10 centimeters (cm) past the tip of the sheath.Insert the introducer dilator over the wire into the sheath.Withdraw the sheath and dilator as a unit.Remove the wire guide." based on the information provided, examination of the returned product, and the results of our investigation, the root cause for this event was determined to be handling/ user technique as the sheath and dilator were not withdrawn as a unit.Appropriate measures have been initiated to address this failure mode.Per the 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 RAABE GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7155022
• Report Number: 1820334-2017-04577
• Device Sequence Number: 1786552
• Product Code: DYB
• UDI-Device Identifier: 00827002130692
• UDI-Public: (01)00827002130692(17)200814(10)8139842
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2018

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 Catalogue Number: KCFW-5.0-38-90-RB-RAABE
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/21/2017
• Supplement Date Received by Manufacturer: 02/14/2018
• Initial Report FDA Received Date: 12/29/2017
• Supplement Report FDA Received Date: 02/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1