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

Model Number	N/A
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	07/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: lead tech.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported that the hemostatic valve of two flexor high-flex ansel guiding sheaths separated from the devices during an endovascular aneurysm repair.Access was gained via the right femoral artery to target the superior mesenteric artery.Each device was used over a glide wire.During removal of each device, the hemostatic valve separated from the device.The devices were pulled by the hub during removal.The dilator was in place during removal and separation of each device.A third device of the same type was used to successfully complete the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional intervention due to this occurrence.The patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Summary of event: it was reported that the hemostatic valve of two flexor high-flex ansel guiding sheaths separated from the devices during an endovascular aneurysm repair.Access was gained via the right femoral artery to target the superior mesenteric artery.Each device was used over a glide wire.During removal of each device, the hemostatic valve separated from the device.The devices were pulled by the hub during removal.The dilator was in place during removal and separation of each device.A third device of the same type was used to successfully complete the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional intervention due to this occurrence.The patient did not experience any adverse effects due to this occurrence.Investigation evaluation: reviews of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, and quality control procedures were conducted during the investigation.A visual inspection of the device was also conducted.The customer returned 2 of the same device to cook for investigation.A physical examination of the returned devices showed 2 devices in used and damaged condition.Each device was received with the flexible dilator inserted.The sheath to both devices were confirmed to have separated from the check flo assembly.No damage was present to the shaft of either sheath.No material was left inside the check flo valve.In response to this incident, cook completed a review of the device history record (dhr).The dhr of the same lot reported 2 non-conformances.Cook concluded that both 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.Cook concluded that no nonconforming product from this lot exists in house or in the field.The device master record was also reviewed and sufficient controls are in place to address the reported failure mode.The product's instructions for use (ifu) includes the following information related to the 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 that sufficient inspection activities are in place to identify this failure mode prior to distribution.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.The risk analysis for this failure mode was reviewed and no additional escalation was required.Cook notified the appropriate personnel and will continue to monitor for similar complaints.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 new patient or event information to report since the previous medwatch report was submitted.

• 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
• MDR Report Key: 12214147
• Report Number: 1820334-2021-01854
• Device Sequence Number: 14248178
• Product Code: DYB
• UDI-Device Identifier: 00827002562332
• UDI-Public: (01)00827002562332(17)240312(10)13820458
• 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: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2021

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: 03/12/2024
• Device Model Number: N/A
• Device Catalogue Number: KCFW-8.0-35-55-RB-HFANL0-HC
• Device Lot Number: 13820458
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2021
• Initial Date Received by Manufacturer: 07/15/2021
• Supplement Date Received by Manufacturer: 10/08/2021
• Initial Report FDA Received Date: 07/22/2021
• Supplement Report FDA Received Date: 10/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR