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

Model Number	N/A
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	10/02/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported during a superficial femoral artery procedure the introducer was disconnected from the ring resulting in heavy bleeding for the patient.Another introducer was then successfully used to complete the procedure.No further consequences were reported.The patient did not require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable or unchanged.Title: pharmacy assistant.(b)(4).From updated information: "the patient experienced adverse effects due to this occurrence.As cc form: important patient bleeding".Investigation - evaluation a review of the complaint history, drawing, 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.One used kcfw was returned for investigation with the check-flo assembly separated from the sheath.The dilator was returned as well, but was not inserted into the sheath.The flare was found to be out of round, with a ruffled appearance.Also, white stress marks were observed on the interior of the flare.The device is shipped with an instruction for use (ifu) that describes the intended use, specific items are addressed such as: warnings: before withdrawing the sheath through tortuous anatomy, insert the introducer dilator to avoid possible breakage.Precautions: do not attempt to insert or withdraw the wire guide and/or introducer if resistance is felt.Upon removal from package, inspect the product to ensure no damage has occurred.Based on the visual inspection of the complaint device, it is feasible to suggest that the device received force beyond it's intended design.We will continue to monitor for similar complaints.Per the risk assessment no further action is required.
Event or Problem Description
It was reported that during a superficial femoral artery procedure, the introducer was disconnected from the ring, resulting in heavy bleeding for the patient.Another introducer was successfully used to complete the procedure.No further consequences were reported.The patient did not require any additional procedures due to this occurrence.

• Brand Name: FLEXOR BALKIN GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6076404
• Report Number: 1820334-2016-01184
• Device Sequence Number: 611128
• Product Code: DYB
• UDI-Device Identifier: 00827002103849
• UDI-Public: (01)00827002103849(17)190425(10)6912259
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: KCFW-7.0-38-40-RB-BLKN
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/05/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/03/2016
• Supplement Report FDA Received Date: 11/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 80 YR