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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported that a flexor high flex ansel guiding sheath was used for a thoracal abdominal endovascular aneurysm repair.The device was introduced in the usual fashion.Upon removal of the dilator, the dilator hub separated from the dilator itself.The end user was able to grab the dilator and remove it safely.The dilator and hub components were saved for return and evaluation.The sheath was already in when the dilator broke.The procedure was finished with this sheath.No unintended section of the device remained inside the patient's body and the patient did not require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
A review of the complaint history, drawings, dimensional verification, device history record, documentation, manufacturing instructions, quality control and visual inspection of the returned device was conducted during the investigation.The complaint dilator was returned for evaluation; the sheath was not returned.Visual inspection revealed that the proximal fitting had separated from the shaft of the dilator.No other notable damage was observed.The flare size (diameter) was measured using calipers and was found to be within specification.Also, the inner diameter of the connector cap was measured using pin gauges, and was found to be within specification.Review of device history record shows no nonconforming events which could contribute to this failure mode.This complaint is the third reported complaint associated to the complaint lot.Based on the provided information and results of the investigation, a definitive root cause cannot conclusively be determined.Measures have been previously initiated to address this issue.The appropriate personnel will be notified and monitoring for similar complaints will continue.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6661053
• Report Number: 1820334-2017-01387
• Device Sequence Number: 1616121
• Product Code: DYB
• UDI-Device Identifier: 00827002562790
• UDI-Public: (01)00827002562790(17)190324(10)6837580
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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): 07/18/2017

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-12.0-35-45-RB-HFANL0-HC
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/23/2017
• Supplement Date Received by Manufacturer: 07/10/2017
• Initial Report FDA Received Date: 06/22/2017
• Supplement Report FDA Received Date: 07/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1