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 Consequences Or Impact To Patient (2199)
Date of Event	01/29/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is being submitted past the 30 day reporting requirement as part of a retrospective review of the report that was initiated during an fda inspection.A retrospective review of the complaint record determined that this report should have been submitted as a malfunction report.In this case, no patient injury occurred; however, this may be likely to cause or contribute to a serious injury if it recurred.(b)(4).The reported device was not returned for evaluation.Photographic images of the reported device were provided.A review of the images found the dilator flare is not of adequate size.No similar complaints have been reported for this lot number.It is feasible to suggest the flare being inadequate is the reason for the fitting becoming separated.
Event or Problem Description
It was reported that during a biliary stone removal procedure, the hub separated from the dilator.The physician completed the procedure.The patient was unharmed and no additional procedures or intervention was required due to this occurrence.No additional details have been received.
Additional Manufacturer Narrative
A review of the complaint history, drawings, device history record, manufacturing instructions, trends, quality control, and visual inspection of photographs of the device was conducted during the investigation.The complaint device was not returned; therefore no physical examination could be performed.However, the customer did provide a photo.Reviewing the photo found the dilator flare is not of adequate size.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.It is feasible to suggest the flare being inadequate is the reason for the fitting becoming separated.However, since the complaint device was not returned, we cannot confirm that the dilator flare was not manufactured to specification.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.
Event or Problem Description
It was reported that during a biliary stone removal procedure, while being placed through the belly button, the hub of a flexor high-flex ansel guiding sheath separated from the dilator as it was inserted into the sheath while the dilator was being removed.The physician was still able to use the device and completed the procedure.The patient was unharmed and no additional procedures or intervention was required due to this occurrence.No additional details have been received.

• 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: 6291719
• Report Number: 1820334-2017-00258
• Device Sequence Number: 13707328
• Product Code: DYB
• UDI-Device Identifier: 00827002477018
• UDI-Public: (01)00827002477018(17)180721(10)6049497
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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-HFANL1-HC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/04/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/31/2017
• Supplement Report FDA Received Date: 06/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1