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

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A review of the complaint history, device history record, instructions for use (ifu), quality control, and visual inspection of the returned device was conducted during the investigation.One sheath was returned with the 0.038" dilator inserted and the 0.018" dilator still in the package.Biomatter was present on the 0.038" dilator and the sheath.The distal tip of the sheath had hangnail damage and accordion characteristics.The transition from the sheath tip to the dilator shaft was not smooth.The dilator tip also had slight hangnail damage.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.There was one other reported complaint for this lot number.The root cause is likely that user technique may have contributed to the failure mode of the complaint device.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.
Event or Problem Description
It was reported that during a procedure to address peripheral artery occlusive disease, the flexor ansel guiding sheath with dilator was not smooth; the physician could not insert the flexor into the patient's vessels.During investigation it was ascertained that the distal tip of the sheath had hangnail damage and accordion characteristics along with slight hangnail damage on the dilator tip.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.
Additional Manufacturer Narrative
Investigation - evaluation: the sheath and both the 0.018" and 0.038" endhole dilators of the flexor ansel guiding sheath were returned.The 0.018" endhole dilator was returned in the sealed inner pouch.The used 0.038" endhole dilator was returned inserted into the sheath.The 0.038" endhole dilator was removed from the sheath and both were examined.The 0.038" endhole dilator was reinserted with no difficulty.A 0.5 mm wrinkle was noted at distal tip of sheath.A 0.1 mm cut was present in the distal tip of the dilator.The transition from the sheath tip to the shaft of the dilator was disrupted by the noted distal sheath tip damage.The device is shipped with an instruction for use (ifu) that describes the intended use.Specific items addressed include: precautions: this product is intended for use by physicians trained and experienced in diagnostic and interventional techniques.Standard techniques for placement of vascular access sheaths should be employed.Do not attempt to insert or withdraw the wire guide and/or introducer if resistance is felt.Sheath introduction: insert the dilator completely into the introducer.If using an introducer with aq hydrophilic coating, activate hydrophilic coating by wetting the outer surface of the device with heparinized saline.Note: for best results, maintain wetted condition of device during placement.Using standard seldinger technique, access the target vessel with the appropriate needle.Insert wire into the vessel through the needle, then remove needle, leaving the wire guide in place.Insert dilator/sheath combination over wire guide.Remove wire guide and dilator, aspirate and flush introducer side-arm." per the quality engineering risk assessment no further action is required.

• 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: 6629829
• Report Number: 1820334-2017-01231
• Device Sequence Number: 16388564
• Product Code: DYB
• UDI-Device Identifier: 00827002491007
• UDI-Public: (01)00827002491007(17)190921(10)7291694
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2017

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-8.0-18/38-45-RB-ANL1-HC
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/16/2017
• Supplement Date Received by Manufacturer: 07/06/2017
• Initial Report FDA Received Date: 06/09/2017
• Supplement Report FDA Received Date: 07/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1