MAUDE Adverse Event Report: COOK INC FLEXOR 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	07/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A supplemental report will be submitted upon completion.
Event or Problem Description
It was reported that a flexor ansel guiding sheath was being used for an embolectomy when the "side arm" and hub separated from the sheath.The device was inserted in the femoral artery in the groin region, and another manufacturer's device was being used within the sheath.The device began to separate upon removal, and the dilator was reinserted to successfully remove the sheath from the patient.No adverse events have been reported regarding this occurrence.
Additional Manufacturer Narrative
A review of the complaint history, device history record, documentation, instructions for use (ifu), and quality control was conducted during the investigation.The device history record for the subassembly lot was reviewed and two nonconformances were noted.The nonconformance forms attached to the work order detail that 1 sheath was nonconforming for sheath endhole damage and 1 device was nonconforming for leakage.The 2 nonconforming devices were scrapped and not replaced.These nonconformances do not appear to be related to the failure mode of the complaint device.The complaint device was not returned; therefore no physical examination could be performed.A representative flexor ansel guiding sheath (kcfw-8.0-18/38-45-rb-anl0-hc) from lot 7912697 was obtained for investigation.No non-conformities were noted.The.038 inch dilator was easily able to inserted into the sheath.A smooth transition is noted.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.Based on the information provided, no product returned, and the results of our investigation; a definitive root cause could not be determined.Measures have been conducted to address this failure mode.Monitoring will continue to be performed for similar complaints.

• 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: 6746734
• Report Number: 1820334-2017-02096
• Device Sequence Number: 1444964
• Product Code: DYB
• UDI-Device Identifier: 00827002490994
• UDI-Public: (01)00827002490994(17)200515(10)7912697
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2017

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-8.0-18/38-45-RB-ANL0-HC
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/13/2017
• Supplement Date Received by Manufacturer: 10/09/2017
• Initial Report FDA Received Date: 07/27/2017
• Supplement Report FDA Received Date: 10/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1