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

Model Number	N/A
Medical Device Problem Codes	Material Separation (1562); Unraveled Material (1664)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The reported device has been received, an evaluation is in progress.The reported device has been received, an evaluation is in progress.
Event or Problem Description
It was reported that during an ivc filter retrieval the flexor guiding sheath unravelled when being used.The patient was unharmed.No additional details were received at this time.
Additional Manufacturer Narrative
(b)(4).Evaluation narrative: a review of the complaint history, drawings, dimensional verification, device history record, documentation, instructions for use (ifu), manufacturing instructions, specifications, trends, quality control, and visual inspection of the returned device was conducted during the investigation.There is no evidence to suggest the product was not made to specifications.Review of the device history record shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.Design verification and validation activities are in place to ensure that this device meets design requirements, and that the device meets the needs of the user.One flexor guiding sheath was returned and examined.The liner was extending out the distal tip of the sheath by approximately 2.0 cm.The distal tip of the sheath was wrinkled.A 0.161" sheath checker was advanced through the proximal fitting.No resistance was met until reaching the distal end.Additional force was required to advance the checker fully through the tubing once it reached the distal end.Based on the available information, the exact cause of the reported issue is not clear.It may be attributed to the patient¿s clinical condition which could have caused the distal tip to wrinkle up, and/or the healthcare professional¿s technique/procedure while retrieving the ivc filter.A definitive root cause cannot be determined.Measures have been conducted to address this failure mode.Per the quality engineering risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.

• Brand Name: FLEXOR GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6412918
• Report Number: 1820334-2017-00402
• Device Sequence Number: 919390
• Product Code: DYB
• UDI-Device Identifier: 00827002323735
• UDI-Public: (01)00827002323735(17)190829(10)7232456
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2017

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-12.0-38-40-RB
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/17/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/17/2017
• Supplement Report FDA Received Date: 06/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1