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 Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Event is still under investigation at this time.
Event or Problem Description
During a leg procedure, while the physician was removing the sheath, it separated from the hub.There was enough of the device outside of the patient that the physician was able to grab it and continue to remove from the patient by hand.No harm to the patient and no other devices were used as the procedure was competed.A section of the device did not remain inside the patient's body.The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation: a review of the complaint history, dimensional verification, 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 one (1) used/damaged kcfw-5.0-18/38-45-rb-anl2-hc was returned for investigation with the hub separated from the sheath.The flare of the device was found to be stretched and had a ruffled appearance.A document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.The process of attaching threaded proximal end fittings to flexor sheaths is validated.The process validation shows that the device meets tensile requirements per iso 11070:2014.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, examination of the returned device and the results of our investigation, it is feasible to suggest that during the removal process the device met force beyond its intended design.We will continue to monitor for similar complaints.Per the health risk assessment no further action is required.
Event or Problem Description
During a leg procedure, while the physician was removing the sheath, it separated from the hub.There was enough of the device outside of the patient that the physician was able to grab it and continue to remove from the patient by hand.No harm to the patient and no other devices were used as the procedure was competed.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.

• 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: 5728766
• Report Number: 1820334-2016-00430
• Device Sequence Number: 18860772
• Product Code: DYB
• UDI-Device Identifier: 00827002301177
• UDI-Public: (01)00827002301177(17)190209(10)6721402
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2016

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 Model Number: N/A
• Device Catalogue Number: KCFW-5.0-18/38-45-RB-ANL2-HC
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/25/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/16/2016
• 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