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

Model Number	G56232
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter occupation: lead tech.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 unknown procedure the hub of a flexor high-flex ansel guiding sheath separated from the rest of the sheath.The user was attempting to deploy a stent through the sheath when the hub separated.The stent and sheath were then removed without issue.It is unknown how the procedure was completed.No adverse effects to the patient were reported.Additional information was requested.
Event or Problem Description
Information was inadvertently omitted from the initial report: after the stent was removed, another cook sheath was used to complete the procedure.
Additional Manufacturer Narrative
Event summary: as reported, during an unknown procedure the hub of a flexor high-flex ansel guiding sheath separated from the rest of the sheath.The user was attempting to deploy a stent through the sheath when the hub separated.The stent and sheath were then removed without issue.After the stent was removed, another cook sheath was used to complete the procedure.No adverse effects to the patient were reported.Investigation ¿ evaluation: a visual inspection of the returned device was conducted.A document-based investigation was also performed including a review of complaint history, device history record (dhr), the instructions for use, manufacturing instructions, and quality control data.The customer returned one device to cook for investigation.Physical examination of the returned device showed: visual inspection results noted that one device was returned in used condition.The sheath was separated from the check flo body.In response to this incident, cook completed a review of the dhr.The dhr for the reported complaint device lot reported 0 non-conformances, and sub assembly had 3 reported non-conformances.Cook concluded that all 3 non-conformances were not related to this incident.A database search for complaints on the reported lot found no additional complaints reported from the field.At this time, cook concluded that no nonconforming product from this lot exists in house or in the field.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: "warnings¿: ¿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.¿ ¿reinsertion of dilator prior to removal of flexor sheath increases the strength of the sheath and lessens the risk of device separation.If resistance i anticipated or encountered during withdrawal of flexor sheath, consider carefully reinserting the dilator prior to continuing removal.¿ ¿precautions¿: ¿in order to ensure device compatibility, choose a sheath size large enough to accommodate the maximum outer diameter of any devices that will be placed through the sheath.¿ ¿all interventional or diagnostic instruments used with this product should move freely through the valve and sheath to avoid damage.¿ ¿sheath removal¿: ¿insert a wire guide until its tip extends at least 10cm past the tip of the sheath.¿ ¿remove the sheath.Avoid applying traction to the hub during removal.If resistance is anticipated or encountered during withdrawal of the flexor sheath, consider reinserting the dilator and removing the sheath and dilator as a unit.¿ ¿remove the wire guide.¿ ¿how supplied¿: ¿upon removal from package, inspect the product to ensure no damage has occurred.¿ cook has concluded a component failure contributed to this failure mode.The complaint was confirmed based on customer testimony and examination of the returned device.There is no evidence that the device was manufactured out of specification.Per the quality engineering risk assessment, no further action is warranted.Cook medical will continue to monitor this device via the complaints database for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 12145273
• Report Number: 1820334-2021-01737
• Device Sequence Number: 4154823
• Product Code: DYB
• UDI-Device Identifier: 00827002562325
• UDI-Public: (01)00827002562325(17)240331(10)13860630
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K142829
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2021

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: 03/31/2024
• Device Model Number: G56232
• Device Catalogue Number: KCFW-7.0-35-55-RB-HFANL0-HC
• Device Lot Number: 13860630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/29/2021
• Supplement Date Received by Manufacturer: 11/10/2021
• Initial Report FDA Received Date: 07/09/2021
• Supplement Report FDA Received Date: 11/12/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown