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

Catalog Number	KCFW-7.0-18/38-45-RB-ANL2-HC
Medical Device Problem Codes	Kinked (1339); Split (2537)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/14/2017
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 that prior to a procedure, the flexor ansel guiding sheath tip was observed to be split/ kinked.The sheath did not come into contact with a patient.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, quality control, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that the (b)(4)" dilator had two cuts present on the distal tip.One cut was measured to be (b)(4) in length, and the other was measured to be (b)(4 in length.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.It is possible, however, that package handling related to shipment and storage conditions, could have contributed to the event.We will continue to monitor for similar complaints.Per the quality engineering risk assessment, no further action is required.

• Brand Name: FLEXOR ANSEL GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7151423
• Report Number: 1820334-2017-04571
• Device Sequence Number: 19042723
• Product Code: DYB
• UDI-Device Identifier: 00827002299863
• UDI-Public: (01)00827002299863(17)200522(10)7930427
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2018

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-7.0-18/38-45-RB-ANL2-HC
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/15/2017
• Supplement Date Received by Manufacturer: 03/08/2018
• Initial Report FDA Received Date: 12/28/2017
• Supplement Report FDA Received Date: 04/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1