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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/12/2015
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.Investigation - evaluation: a review of the complaint history, instructions for use (ifu), trends and quality control was conducted during the investigation.A document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.The device is shipped with an instruction for use (ifu) that describes the intended use, specific items are addressed such as: "insert the introducer dilator over the wire into the sheath.Withdraw the sheath and dilator as a unit." based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.
Event or Problem Description
Customer reported that the device was used in an angioplasty/ leg run-off procedure.The device broke at the hub while the attending was attempting to remove the device."everything was removed from the patient's body" and the procedure was completed with a new device.A section of the device did not remain inside the patient's body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.No further event or patient information was provided.

• 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: 6291507
• Report Number: 1820334-2017-00252
• Device Sequence Number: 11153918
• Product Code: DYB
• UDI-Device Identifier: 00827002322240
• UDI-Public: (01)00827002322240(17)180624(10)5982100
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 08/31/2015

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-6.0-38-40-RB-BLKN-HC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2015
• Initial Report FDA Received Date: 01/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1