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

Model Number	G29999
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Pma/510(k) number = pre-amendment.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
As reported, during an endovascular treatment procedure, the tip of a flexor ansel guiding sheath frayed.Access was obtained in the right femoral artery.As the user attempted to insert the sheath, the tip of the device became caught in the puncture site and frayed.No calcification was noted at the puncture sire.Another device of the same type was used to complete the procedure.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Event summary: as reported, during an endovascular treatment procedure, the tip of a flexor ansel guiding sheath frayed.Access was obtained in the right femoral artery.As the user attempted to insert the sheath, the tip of the device became caught in the puncture site and frayed.No calcification was noted at the puncture sire.Another device of the same type was used to complete the procedure.Investigation - evaluation.Reviews of the complaint history, device history record, drawing, instructions for use (ifu), and quality control procedures of the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document-based investigation evaluation was conducted.A review of the device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Reviews of quality control procedures and drawings were also conducted, and no gaps were discovered.The available information provides objective evidence to support that the device was manufactured to specification.The device is packaged with instructions for use, which warn, "if resistance is encountered during advancement of flexor sheath, assess cause of resistance and consider dilation of any restriction identified or consider alternate treatment strategy.If flexor sheath is advanced through resistance, force to remove the sheath will be higher, increasing the risk of sheath material or hub separation upon withdrawal." the ifu also states, ¿upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the information provided, investigation has concluded that a cause for the device failure could not be established.Possible reasons for the failure include the patient's anatomy, the nature of the procedure, and/or user handling.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment, no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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: 9539563
• Report Number: 1820334-2020-00039
• Device Sequence Number: 2426565
• Product Code: DYB
• UDI-Device Identifier: 00827002299993
• UDI-Public: (01)00827002299993(17)220509(10)9727767
• Combination Product (Y/N): N
• PMA/510(K) Number: K142829
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2020

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 Expiration Date: 05/09/2022
• Device Model Number: G29999
• Device Catalogue Number: KSAW-7.0-18/38-55-RB-ANL1-HC
• Device Lot Number: 9727767
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/17/2019
• Supplement Date Received by Manufacturer: 03/26/2020
• Initial Report FDA Received Date: 01/02/2020
• Supplement Report FDA Received Date: 04/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1