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

Catalog Number	KCFW-6.0-18/38-45-RB-ANL2-HC
Medical Device Problem Codes	Material Frayed (1262); Device Damaged Prior to Use (2284)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Date of Event	06/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
It was reported that, prior to patient contact, while being prepped on the back table, it was noted the end of the sheath was allegedly frayed/split.As a result, another device was used for the procedure.No adverse events to the patient were reported.
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation: a review of the complaint history, drawings, device history record, documentation, instructions for use (ifu), manufacturing instructions, trends, quality control, and visual inspection of the returned device was conducted during the investigation.The flexor ansel guiding sheath was returned for investigation with the 0.038" endhole dilator inserted.The 0.018" endhole dilator was also returned, and was still in the sealed inner package.Photographs were taken throughout the physical examination and are located in the attached files of the complaint.Biomatter was present on the dilator taper and sheath distal tip at the damaged section.No damage was noted to the 0.038" endhole dilator tip.The 0.038" dilator was removed from the sheath, and additional biomatter was noted on the dilator shaft once it was removed.The sheath tip was examined and no tears or frays were observed.Dried biomatter was present on the wrinkled section of the tip.Therefore, the sheath tip was wiped clean for further examination.The distal edge of the sheath was wrinkled, but no tears or frays were found.A document-based investigation was performed.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, examination of the returned product, and the results of our investigation; a definitive root cause could not be determined.Measures have been conducted to address this failure mode.The appropriate personnel have been notified and 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: 6732446
• Report Number: 1820334-2017-01686
• Device Sequence Number: 652537
• Product Code: DYB
• UDI-Device Identifier: 00827002299832
• UDI-Public: (01)00827002299832(17)200426(10)7863041
• 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,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2017

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 Catalogue Number: KCFW-6.0-18/38-45-RB-ANL2-HC
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/27/2017
• Supplement Date Received by Manufacturer: 10/23/2017
• Initial Report FDA Received Date: 07/21/2017
• Supplement Report FDA Received Date: 11/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1