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

Catalog Number	KCFW-8.0-35-55-RB-HFANL1-HC
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/04/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
During a procedure for peripheral artery occlusion disease, left leg of the (b)(6) year old male patient, the hub and shaft separated when the physician attempted to pull back the balloon.Another device was used to complete the procedure.The outcome of the patient reported to have been good.
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation: a review of the complaint history, device history record, manufacturing instructions, trends, quality control and visual inspection of the returned device was conducted during the investigation.The visual inspection of the returned device reported that the flare had buckled back around the sheath.Therefore, the flare was not tested with a go no-go flare gauge.The complaint device was returned therefore, an investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.Review of device history record shows 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, and the results of our investigation, a definitive root cause could not be determined.It is possible that the sheath had not been positioned properly during the capping manufacturing process, which could have caused the sheath flare to buckle, thus resulting in a looser fit between the sheath and check-flo valve.Also, it is possible that the balloon had not been fully deflated before attempting to remove the catheter from the sheath, which then would have provided a source of resistance during removal, thus excessive force may have been used to remove the device.We will continue to monitor for similar complaints.Per the health risk assessment no further action is required.
Event or Problem Description
During a procedure for peripheral artery occlusion disease, left leg of the (b)(6) year old male patient, the hub and shaft separated when the physician attempted to pull back the balloon.Another device was used to complete the procedure.The outcome of the patient reported to have been good.

• 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: 5527052
• Report Number: 1820334-2016-00156
• Device Sequence Number: 13541116
• Product Code: DYB
• UDI-Device Identifier: 00827002490451
• UDI-Public: (01)00827002490451(17)180630(10)NS5999045
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2016

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-8.0-35-55-RB-HFANL1-HC
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/04/2016
• Device Age: 9 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/07/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/25/2016
• Supplement Report FDA Received Date: 12/07/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 74